ASTHMA MONITOR MODEL, AM1

• K Number: K090486
• Device Name: ASTHMA MONITOR MODEL, AM1
• Manufacturer: CARDINAL HEALTH GERMANY 234 GMBH
• Date Cleared: 2009-05-06 ( 70 days)
• Product Code: BZG
• Regulation Number: 868.1840

Intended Use

The Asthma Monitor AM1+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM1+ / AM1+ BT measures the flow during expiration serving for the calculation of further parameters as FEV1. The AM1+ / AM1+ BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician. The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM1+ / AM1+ BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS. The AM1+ / AM1+ BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM1+ / AM1+ BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine. The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission.

Device Description

The Asthma Monitor AM1+ / AM1+ BT is a medical device (peak flow meter with symptom diary) providing following characteristics: - Handheld device . - Battery operation . - Storing capacity of 400 measurements / 2000 entries . - Measurement Parameters: PEF and FEV1 . - Accuracy Flow: ± 5% or ± 20 l/min . - Accuracy Volume: ± 3% or ± 0.05 liter . - Data transmission to computer via Bluetooth and Serial (AM1+ BT) . - Data transmission to computer via Serial (AM1+) . - Flow sensor (single patient use) . - Mouthpiece (single patient use) .

Predicate Devices

K980676

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard electronic measurement and data storage, with no mention of AI or ML algorithms for analysis or interpretation.

Therapeutic

No
The device is described as an "electronic measurement device to monitor the lung function" and a "medical device (peak flow meter with symptom diary)," used to measure and monitor respiratory status, not to provide therapy or treatment.

Diagnostic

Yes

This device is an electronic measurement device that monitors lung function by measuring respiratory flows and volume. It calculates parameters like FEV1 and provides numeric values and a visual control unit (traffic lights) for immediate indication based on criteria defined by a physician. This process of measuring physiological parameters to assess the health status and aid in diagnosis or monitoring of conditions like asthma and COPD aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Handheld device" with "Battery operation" and includes a "Flow sensor" and "Mouthpiece," indicating it has physical hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Asthma Monitor AM1+ / AM1+ BT is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
• Device Function: The Asthma Monitor AM1+ / AM1+ BT measures respiratory flows and volumes directly from the patient's breath (in vivo). It does not analyze specimens like blood, urine, or tissue samples.
• Intended Use: The intended use is to monitor lung function in patients with conditions like asthma and COPD by measuring parameters like PEF and FEV1 from their breath.

Therefore, the device operates by directly interacting with the patient's body (measuring exhaled air) rather than analyzing samples taken from the body. This clearly places it outside the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Asthma Monitor AM1+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproduciblity montal the long tenction (decemination of the AM1+ BT measures the flow during expiration serving for the calculation of further parameters as FEV1.

Serving for the Galcallon of farmer parame constitution of human beings in the areas assimma, The AM1+ / AM1+ BT is used to monitor the respiratory status of high stiring kri chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.

The patient is informed of the results by numeric values for selected parameties (e.g. PEF, FEN1). The patient is themica of the results by hall as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.

the medion saves the results of a measurement (always with date and time) automatically in an i ne uevice saves the results of a measuromic (and on to 400 measurements. In addition, a interial catabase. The momery capacity to be of a software package (AMOS) to record systems questionally of Life" status. When enabled, the AM1+ BT can be programmed with a couple of the "Quality of the "battle" which shart can a couple of different in the standord IS. which the standard DC vising the quostons, whole the patiently be and can be transmitted for evaluation to a standard PC using the software package AMOS.

Sultware package AMOO. The AM1+ / AM1+ BT is designed to replace ordinary peak flow meter diary AM1 / AM1+ BT being t ric XMT+ 7 threadling, sturdy and handy design allow the Asthma Monton AM1+ / AM1+ BT being uyerent. Eddy manaling, est work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.

The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission.

Product codes (comma separated list FDA assigned to the subject device)

BZG

Device Description

The Asthma Monitor AM1+ / AM1+ BT is a medical device (peak flow meter with symptom diary) providing following characteristics:

• Handheld device .
• Battery operation .
• Storing capacity of 400 measurements / 2000 entries .
• Measurement Parameters: PEF and FEV1 .
• Accuracy Flow: ± 5% or ± 20 l/min .
• Accuracy Volume: ± 3% or ± 0.05 liter .
• Data transmission to computer via Bluetooth and Serial (AM1+ BT) .
• Data transmission to computer via Serial (AM1+) .
• Flow sensor (single patient use) .
• Mouthpiece (single patient use) .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

The Asthma Monitor can be used for patients from 4 years on and older.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Bluetooth data transmission for the above device was developed in accordance with the Cardinal Health development standard operating procedures (000490 06 - Design Control).

The risk analysis method used to assess the impact of Asthma Monitor AM1+ / AM1+ BT with the additional Bluetooth data transmission was a Failure Modes and Effects Analysis (FMEA).

Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards.

The EMC testing was performed according EN 60601-1-2.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K980676

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).

Summary

0

5 510(k) Summary

K090486

510(k) Summary

GENERAL INFORMATION

MAY - 6 2009

Type of Submission 5.1

Special 510(k) Submission

Submission date: 02/17/2009

5.2 Submitter

Name:

Cardinal Health Germany 234 GmbH

Address:

Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany:

Address:

Phone: FAX: E-mail

Phone / FAX:

E-mail

Thomas Rust Cardinal Health Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany [phone] - 383 [phone] - 62383 Thomas. Rust(@cardinalhealth.com

Contact person in the U.S .: (Official Correspondent) Address

Thomas Gutierrez Cardinal Health 22745 Savi Ranch Parkway Yorba Linda, CA 92887 (714) - 919 - 3342 Thomas. [e-mail]

Cardinal Health

AM1+ / AM1+ BT
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5.3 Establishment Registration Number 9615102

Common Name or Classification Name 5.4 Diagnostic Spirometer (CFR 868.1840, Product Code BZG)

5,5 Trade Name Asthma Monitor AM1+ Asthma Monitor AM1+ BT

ર.6 Device Classification This is a Class II device

5.7 Classification Panel 73 Anesthesiology Part 868 Code BZG

Reason for Premarket Notification 5.8 Device modification to an existing Cardinal Health - device regarding "The New 510(k) Paradigm"

Legally predicate marketed device 5.9 Asthma Monitor AM2 Code BZG K980676

Predicate Device Company 5.10

Cardinal Health Germany 234 GmbH

5.11 Device Description

The Asthma Monitor AM1+ / AM1+ BT is a medical device (peak flow meter with symptom diary) providing following characteristics:

• Handheld device .
• Battery operation .
• Storing capacity of 400 measurements / 2000 entries .
• Measurement Parameters: PEF and FEV1 .
• Accuracy Flow: ± 5% or ± 20 l/min .
• Accuracy Volume: ± 3% or ± 0.05 liter .
• Data transmission to computer via Bluetooth and Serial (AM1+ BT) .
• Data transmission to computer via Serial (AM1+) .
• Flow sensor (single patient use) .
• Mouthpiece (single patient use) .

Cardinal Health

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5.12 Intended Use Statement

The Asthma Monitor AM1+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM1+ / AM1+ BT measures the flow during expiration serving for the calculation of further parameters as FEV1.

The AM1+ / AM1+ BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.

The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM1+ / AM1+ BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.

The AM1+ / AM1+ BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM1+ / AM1+ BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.

The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission.

5.13 Reguired Components

Asthma Monitor AM1+ / AM1+ BT Accessories User Manual

Cardinal Health

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5.14 Summary Table of Comparison

| | Asthma Monitor AM2
(K980876) | Asthma Monitor AM1+
/ AM1+ BT |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Asthma Monitor AM2 from JAEGER is
an electronic measurement device to
monitor the lung function (determination of
the respiratory flows and volume) with high
reproducibility wherever and
whenever is a need of. The AM2
measures the flow during expiration
serving for the calculation of further
parameters as FEV1, FVC or FEF25-75.
The AM2 is used to monitor the respiratory
status of human beings in the areas
asthma, chronic obstructive pulmonary
disorder and in areas like occupational
medicine, clinical trials and disease
management.
The patient is informed of the results by
numeric values for selected parameters
(e.g. PEF, FEVI).
Furthermore a visual control unit,
displayed as a kind of traffic lights, allows
an immediate indication of the
measurement based on criteria defined by
the patient's physician.
The device saves the results of a
measurement (always with date and time)
automatically in an internal database. The
memory capacity is designed to store up
to 400 measurements. In addition, a
questionnaire functionality can be called
up by the use of a software package
(AMOS) to record e.g. the "Quality of Life"
status .When enabled, the AM2 can be
programmed with up to 12 questions,
where the patient
can select then from up to 7 different
answers. This information is also stored in
the internal database
and can be transmitted for evaluation to a
standard PC using the software package
AMOS.
The AM2 is designed to replace ordinary
peak flow meter, diary and pencil by a
single System. Easy handling, sturdy and
handy design allow the Asthma Monitor
AM2 being used almost everywhere: at
work, at home, in school, for experts
opinion, research or clinical trial purposes
and in occupational medicine. | The Asthma Monitor AM1+ / AM1+ BT
from Cardinal Health is an electronic
measurement device to monitor the lung
function (determination of the respiratory
flows and volume) with high reproducibility
wherever and whenever is a need of. The
AM1+ / AM1+ BT measures the flow
during expiration serving for the
calculation of further parameters as FEV1.
The AM1+ / AM1+ BT is used to monitor
the respiratory status of human beings in
the areas asthma, chronic obstructive
pulmonary disorder and in areas like
occupational medicine, clinical trials and
disease management.
The patient is informed of the results by
numeric values for selected parameters
(e.g. PEF, FEV1). Furthermore a visual
control unit, displayed as a kind of traffic
lights, allows an immediate indication of
the measurement based on criteria
defined by the patient's physician.
The device saves the results of a
measurement (always with date and time)
automatically in an internal database. The
memory capacity is designed to store up
to 400 measurements. In addition, a
questionnaire functionality can be called
up by the use of a software package
(AMOS) to record e.g. the "Quality of Life"
status. When enabled, the AM1+ / AM1+
BT can be programmed with a couple of
questions, where the patient can select
then from a couple of different answers.
This information is also stored in the
internal database and can be transmitted
for evaluation to a standard PC using the
software package AMOS.
The AM1+ / AM1+ BT is designed to
replace ordinary peak flow meter, diary
and pencil by a single system. Easy
handling, sturdy and handy design allow
the Asthma Monitor AM1+ / AM1+ BT
being used almost everywhere: at work, at
home, in school, for experts opinion,
research or clinical trial purposes and in
occupational medicine.
The AM1+ operates with serial data
transmission whereas the AM1+ BT can
be operated with serial and Bluetooth data
transmission. |
| Patient
population | The Asthma Monitor can be used for
patients from 4 years on and older. | Identical |
| Dimensions
(housing) | Length x Width x Height:
1128234 mm
Weight:
145 g (batteries included) | Identical |
| Display | LCD module
Size: 46,0 x 18,4 mm
100 x 32 dots | identical |
| Key-panel | Foil Key-panel (4 keys):

• ESC (on/off)
• UP-ARROW
• DOWN-ARROW
• OK | identical |
  | Housing | Material:
  Rotec ABS 1001FR VD | identical |
  | Integrated
  mouthpiece
  (Flow sensor) | Material:
  Rotec ABS 1001FR VO | Material:
  Polystyrol 454C |
  | Single Use
  mouthpiece
  (optional) | Material:
  Bormed RG835 MO | identical |
  | Performance
  (measurements) | Parameters:
  PEF / FEV1 / FVC / FEF25 / FEF50
  FEF75 / FEF25-75 | Parameters:
  PEF / FEV1 |
  | Interface | Serial RS 232 | Serial RS 232 & Bluetooth |
  | Energy type | 3 x 1,5 (Micro AAA) | identical |
  | Operating
  Require-
  ments | PC software AMOS | Identical |

. Cardinal Health

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AM1+ / AM1+ BT

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5 510(k) Summary

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Cardinal Health

AM1+ / AM1+ BT

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5.15 Summary of Device Testing

The following practices were followed and monitored for development of the Asthma Monitor AM1+ with the Bluetooth data transmission:

The Bluetooth data transmission for the above device was developed in accordance with the Cardinal Health development standard operating procedures (000490 06 - Design Control).

The risk analysis method used to assess the impact of Asthma Monitor AM1+ / AM1+ BT with the additional Bluetooth data transmission was a Failure Modes and Effects Analysis (FMEA).

Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards.

The EMC testing was performed according EN 60601-1-2.

5.16 Conclusions

Based on the above, Cardinal Health Germany 234 GmbH concludes that the Asthma Monitor AM1+ / AM1+ BT is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use, and performs at least as well as the predicate devices.

Cardinal Health

.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardinal Health Germany 234 GmbH C/O Mr. Thomas Gutierrez Director Regulatory Affairs Cardinal Health 207 Incorporated Regulatory Affairs, 1100 Bird Center Drive Palm Springs, California 92262

Re: K090486

Trade/Device Name: Asthma Monitor AM1+ Asthma Monitor AM1+B1 Regulation Number: 868,1840 Regulatory Class: II Product Code: BZG Dated: April 2, 2009 Received: April 6, 2009

Dear Mr. Gutierrez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the dcvice, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting

7

Page 2- Mr. Gutierrez

(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Renner

Susan Runner, D.D.S., M. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

8

Indications for Use

510(k) Number (if known):

K090486

Device Name:

Asthma Monitor AM1+ Asthma Monitor AM1+ BT

Indications for Use:

The Asthma Monitor AM1+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproduciblity montal the long tenction (decemination of the AM1+ BT measures the flow during expiration serving for the calculation of further parameters as FEV1.

Serving for the Galcallon of farmer parame constitution of human beings in the areas assimma,
The AM1+ / AM1+ BT is used to monitor the respiratory status of high stiring kri chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.

The patient is informed of the results by numeric values for selected parameties (e.g. PEF, FEN1). The patient is themica of the results by hall as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.

the medion saves the results of a measurement (always with date and time) automatically in an i ne uevice saves the results of a measuromic (and on to 400 measurements. In addition, a interial catabase. The momery capacity to be of a software package (AMOS) to record systems questionally of Life" status. When enabled, the AM1+ BT can be programmed with a couple of the "Quality of the "battle" which shart can a couple of different in the standord IS. which the standard DC vising the quostons, whole the patiently be and can be transmitted for evaluation to a standard PC using the software package AMOS.

Sultware package AMOO.
The AM1+ / AM1+ BT is designed to replace ordinary peak flow meter diary AM1 / AM1+ BT being t ric XMT+ 7 threadling, sturdy and handy design allow the Asthma Monton AM1+ / AM1+ BT being uyerent. Eddy manaling, est work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational

medicine.

The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pena

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

40

510(k) Number: K040416