K Number

Device Name

FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT

Manufacturer

VIASYS HEALTHCARE GMBH

Date Cleared

2008-06-26

(104 days)

Product Code

BTY DPS

Regulation Number

868.1890

Intended Use

The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry). In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software. FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. FlowScreen / FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients. FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, study nurse, trainer and service personnel). The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm. A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient. Federal U.S. law restricts this device to sale by or on the order of a physician.

Device Description

FlowScreen is an active medical device providing following characteristics: Mains operation Colour LCD display for user interface Alphanumerical keyboard Colour ink-printer for printout of reports in US-letter and DIN A4 size Patient information and measurements are stored in an internal database Data can be stored on an SD memory card a) pulmonary functions Measurement with ultrasonic handle or pneumotach handle . Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ... ) Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, . PIF, ... ) Flow-Volume and Volume-Time Loop, pre/post tests . MVV measurement Trending capabilities Patient Incentive animations Interpretation modules . b) ECG functions . Simultaneous acquisition of the 12 standard leads Storage of 10 seconds of acquired ECG signal . Digital filters for base-line drift and mains interference suppression Interpretation program Hanover ECG System (HES) providing the following . additional information: Representatives templates of each lead including markers on fiducial O points Summary of mean measurements O Rhythm Analysis statements O Signal noise detection and information O Specific findings on QRS complex Conduction statements O QRS T diagnostic statements O Arrhythmia monitoring detection o Heart Rate Variability 0

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K062011, K070614

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The document mentions an "Interpretation program Hanover ECG System (HES)" that provides "additional information" and "diagnostic statements." While this suggests automated analysis, the document does not explicitly state that this program uses AI or ML. Without further information about the HES program's underlying technology, it's impossible to definitively confirm the presence of AI/ML.

Therapeutic

No
Explanation: The device is described as a "diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry)" and for "measuring a 3/6- or 12-channel surface electrocardiogram (ECG)". Its purpose is to provide information for evaluation, not to administer therapy or treatment. The text explicitly states, "no therapy or drugs can be administered based solely on the interpretation statements."

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry)." It also details its use for measuring ECGs, which are used for diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as a "Mains operation Colour LCD display," "Alphanumerical keyboard," "Colour ink-printer," and mentions measurement with "ultrasonic handle or pneumotach handle." It is also powered from a wall outlet. These are physical hardware components, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
Device Function: The FlowScreen / FlowScreen ECG is a diagnostic system that performs:
- Spirometry: Measures pulmonary function by assessing airflow and lung volumes directly from the patient's breathing.
- ECG: Measures the electrical activity of the heart by placing electrodes on the patient's skin. This is a measurement taken from the patient's body, not on a sample taken from the body.

The device directly interacts with the patient to acquire physiological data (breathing and electrical heart signals). It does not analyze samples taken from the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).

In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12-channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.

FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. FlowScreen / FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.

FlowScreen CT (Clinical Trial version) incorporates the identical measurements, but individual access rights are defined for different user roles (e.g. Investigator, study nurse, trainer and service personnel).

The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.

A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.

The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

Product codes

BTY, DPS

Device Description

a) pulmonary functions

Measurement with ultrasonic handle or pneumotach handle .
Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ...)
Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, . PIF, ... )
Flow-Volume and Volume-Time Loop, pre/post tests .
MVV measurement
Trending capabilities
Patient Incentive animations
Interpretation modules .

b) ECG functions

. Simultaneous acquisition of the 12 standard leads
Storage of 10 seconds of acquired ECG signal .
Digital filters for base-line drift and mains interference suppression
Interpretation program Hanover ECG System (HES) providing the following . additional information:
Representatives templates of each lead including markers on fiducial O points
Summary of mean measurements O
Rhythm Analysis statements O
Signal noise detection and information O
Specific findings on QRS complex
Conduction statements O
QRS T diagnostic statements O
Arrhythmia monitoring detection o
Heart Rate Variability 0

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

4 years and older

Intended User / Care Setting

Trained physicians in the office or hospital.

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 following practices were followed and monitored for development of the FlowScreen / FlowScreen ECG / FlowScreen CT:
The risk analysis method used to assess the impact of the FlowScreen with the new option ECG was a Failure Modes and Effects Analysis (FMEA). The risk analysis and risk control document number is 651003 17.
The design validation tests that were performed as a result of this risk analysis assessment and functional specifications are documented in document "Validation test script" and "validation test log" with document number 671003 32 (Test Script), 671003 33 (Test Log), 671003 40 (Test Script Workflow ECG) and 671003 41 (Test Log Workflow ECG).
The safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards. The document numbers for the performed safety tests according IEC 60601-1 are 407.267.2 and 71320123. The document number according IEC60601-2-25 is 407.267.3.
The EMC testing was performed according EN60601-2 with the document numbers 266.182 and 267.281.

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

Not Found

Predicate Device(s)

K062011, K070614

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.1890 Predictive pulmonary-function value calculator.

(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).

Summary

K080734

GENERAL INFORMATION

JUN 2 6 2008

1. Applicant
Date:	May 05th, 2008
Name:	VIASYS Healthcare GmbH (owned by Cardinal Health)
Address:	Leibnizstrasse 7
D-97204 Hoechberg
Germany
Contact person in Germany:
(Official Correspondent)
Address	Thomas Rust
VIASYS Healthcare GmbH
Leibnizstrasse 7, 97204 Hoechberg
Germany
Phone:	+49 931 4972 - 383
FAX:	+49 931 4972 - 62383
E-mail	Thomas.Rust@viasyshc.com
or at: Thomas.Rust@cardinalhealth.com
Contact person in USA:

(US Agent)	Yvette Lloyd
Address	Cardinal Health
	22745 Savi Ranch Parkway
	Yorba Linda, CA 92887
Phone/Fax:	(714) - 919 - 3247
E-mail	Yvette.Lloyd@cardinalhealth.com

2. Trade Name

FlowScreen FlowScreen ECG FlowScreen CT

3. Classification Name

Pulmonary calculator (21 CFR 868.1890, Product Code BTY) Electrocardiograph (21 CFR 870.2340, Product Code DPS)

1. Establishment Registration Number 9615102

5. Facility Address

VIASYS Healthcare GmbH Leibnizstrasse 7 D-97204 Hoechberg Germany

KC80734

Section 513 Device Classification 6.

6.1 Classification

This is a Class II device

6.2 Classification Panel

Panel 73, Anesthesiology Code BTY Panel 74, Circular System Devices, ECG Code DPS

Reason for Premarket Notification 7. New option for FlowScreen K062011 (Combination of two VIASYS devices, K062011 + K070614)

Predicate Devices Descriptions 8.

8.1 Name
a) FlowScreen b) CorScreen
8.2 Predicate Device Company Viasys Healthcare GmbH
8.3 Predicate Device 510(k)# a) K062011 b) K070614

Device Description க்

FlowScreen is an active medical device providing following characteristics:

Mains operation Colour LCD display for user interface Alphanumerical keyboard Colour ink-printer for printout of reports in US-letter and DIN A4 size Patient information and measurements are stored in an internal database Data can be stored on an SD memory card

a) pulmonary functions

Measurement with ultrasonic handle or pneumotach handle .
Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ... ) �
Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, . PIF, ... )
Flow-Volume and Volume-Time Loop, pre/post tests .
MVV measurement �
Trending capabilities �
Patient Incentive animations �
Interpretation modules .

b) ECG functions

. Simultaneous acquisition of the 12 standard leads
Storage of 10 seconds of acquired ECG signal .
Digital filters for base-line drift and mains interference suppression �
Interpretation program Hanover ECG System (HES) providing the following . additional information:
- Representatives templates of each lead including markers on fiducial O points
- Summary of mean measurements O
- Rhythm Analysis statements O
- Signal noise detection and information O
- Specific findings on QRS complex ಂ
- Conduction statements O
- QRS T diagnostic statements O
- Arrhythmia monitoring detection o
- Heart Rate Variability 0

10. Intended Use Statement

The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).

FlowScreen / FlowScreen ECG can be used for non interpretive applications for patients with an age of 4 vears and older and a weight of 20 kg or higher. FlowScreen ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. FlowScreen ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.

The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.

A qualified physician has to reassess all FlowScreen measurements. An interpretation by FlowScreen is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the FlowScreen represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.

The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

Federal U.S. law restricts this device to sale by or on the order of a physician.

11. Required Components

FlowScreen - monitor Ultrasonic handle or pneumotach handle ECG-amplifier Disposable ECG-electrodes User manual

K080734

12. Summary table of comparison

Pulmonary Function
#	Parameter	New Device:
FlowScreen	Predicate Device:
FlowScreen K062011	Result
1	Intended Use	Diagnostic Spirometry
(VCin, VCex, etc.)	Diagnostic Spirometry
(VCin, VCex, etc.)	identical
2	Patient population	To be used as a
screening device to
determine whether or
not a patient requires
further diagnosis for
pulmonary function
disorders	To be used as a
screening device to
determine whether or
not a patient requires
further diagnosis for
pulmonary function
disorders	identical
3	Performance	Slow Spiormetry
Forced Spiormetry
Flow-Volume
MVV
Pre/Post Tests
Trending capabilities
Interpretation modules	Slow Spiormetry
Forced Spiormetry
Flow-Volume
MVV
Pre/Post Tests
Trending capabilities
Interpretation modules	identical
4	Patient user
interface	Ultrasonic handle or
pneumotach handle	Ultrasonic handle or
pneumotach handle	identical
5	Material of
patient user
interface	Pneumotach handle:
Pneumotach (Ultem
1010R, handle (Romira
ABS 1001 FRVO),
mouthpiece
(Polypropylene
RG835MO)
Ultrasonic handle:
handle (Luran S778 TE),
mouthpiece (HDPE
Eraclene MS 80U)	Pneumotach handle:
Pneumotach (Ultem
1010R, handle (Romira
ABS 1001 FRVO),
mouthpiece
(Polypropylene
RG835MO)
Ultrasonic handle:
handle (Luran S778 TE),
mouthpiece (HDPE
Eraclene MS 80U)	identical
6	Patient
contacting
accessories	Mouthpiece
Nose clip
Nose pads	Mouthpiece
Nose clip
Nose pads	identical
7	Material of
patient
contacting
accessories	Nose clip: Polyacetal
Nose pads: Ethylene
Vinyl Acetate	Nose clip: Polyacetal
Nose pads: Ethylene
Vinyl Acetate	identical
8	Dimensional
specification	455 x 280 x 380 (W x H
x D)	455 x 280 x 380 (W x H
x D)	Identical
9	Software	Data acquisition
Data calculation
Calc. of predicted values
Data analysis
Data interpretation
Data storage
Data output
Data input	Data acquisition
Data calculation
Calc. of predicted values
Data analysis
Data interpretation
Data storage
Data output
Data input	Identical

ECG Function
#	Parameter	New Device:
FlowScreen	Predicate Device:
CorScreen K070614	Result
1	Intended Use	3/6- or 12-channel
surface ECG recording
device	3/6- or 12-channel
surface ECG recording
device	identical
2	Input dynamic
range	+/- 300mV @ DC	+/- 300mV @ DC	identical
3	Frequency
response
Bandwidth	0,05 - 150 Hz /
According to EC11 and
IEC 60601-2-51	0,05 - 150 Hz /
According to EC11 and
IEC 60601-2-51	identical
4	A/D conversion	24 bits	24 bits	identical
5	Leads	12 Standard	12 Standard	identical
6	Paper Speed	25 50 mm/s +/-5%
According to EC11	25 50 mm/s +/-5%
According to EC11	identical
7	Recorder
Sensitivity	5 10 20 mm/s
According to EC11	5 10 20 mm/s
According to EC11	identical
8	Writing System	Ink-printer US-letter and
DIN-A4 size	Ink-printer US-letter and
DIN-A4 size	Identical
9	Printed
Channels	1/2/6/12	1/2/6/12	Identical
10	Paper	US-Letter and DIN-A4	US-Letter and DIN-A4	Identical
11	Mode of
operation	Manual	Manual	Identical
12	Input/output	SD Memory card	SD Memory card	Identical
13	Display
14	Size	320 x 240 pixels	320 x 240 pixels	Identical
15	No. of displayed
channels	1/3/6/12	1/3/6/12	Identical
16	Trace speeds	5 10 25 50 mm/s	5 10 25 50 mm/s	Identical
17	Sensitivity	5 10 20 40 mm/mV	5 10 20 40 mm/mV	Identical

KOBA

K080734

Hardware platform
FlowScreen	FlowScreen K062011	CorScreen K070614
Power supply	Identical	Identical
Mainboard	Identical	Identical
Connector board	Identical	Identical
Interfaces	Identical	Identical
Color printer	Identical	Identical
Keyboard	Identical	Identical
Color display	Identical	Identical
Enclosure	Identical	Identical
Hardware patient user interfaces
Patient user interface pneumotach handle	Identical	----------
Patient user interface USS-handle	Identical	----------
ECG Amplifier	----------	Identical
Accessories
Mouthpiece	Identical	----------
Nose clip	Identical	----------
ECG electrodes	----------	Identical
Software / Firmware / Operating System
Boot loader (u-boot)	Identical	Identical
Operating system (Linux)	Identical	Identical
Firmware:
Base module	Identical	Identical
Spirometry module	Identical	----------
ECG module	----------	Identical

K080734

13. Summary of non-clinical performance tests

The following practices were followed and monitored for development of the FlowScreen / FlowScreen ECG / FlowScreen CT:

The risk analysis method used to assess the impact of the FlowScreen with the new option ECG was a Failure Modes and Effects Analysis (FMEA). The risk analysis and risk control document number is 651003 17.

The design validation tests that were performed as a result of this risk analysis assessment and functional specifications are documented in document "Validation test script" and "validation test log" with document number 671003 32 (Test Script), 671003 33 (Test Log), 671003 40 (Test Script Workflow ECG) and 671003 41 (Test Log Workflow ECG).

The safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards. The document numbers for the performed safety tests according IEC 60601-1 are 407.267.2 and 71320123. The document number according IEC60601-2-25 is 407.267.3.

The EMC testing was performed according EN60601-2 with the document numbers 266.182 and 267.281.

Conclusion:

Based on the above, VIASYS HEALTHCARE GMBH concludes, that FlowScreen is determined substantially equivalent to the legally marketed predicate VIASYS devices and is safe and effective for its intended use, and performs at least as well as the predicate devices. The FlowScreen / FlowScreen ECG / FlowScreen CT is a combination of FlowScreen K062011 and CorScreen K070614 on the identical hardware base.

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 resembling an eagle or bird in flight, composed of three curved lines or strokes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2008

Mr. Thomas Rust Regulatory Affairs Manager VIASYS Healthcare GmbH Leibnizstrasse 7 D-97204 Hoechberg GERMANY

Re: K080734

Trade/Device Name: FlowScreen FlowScreen ECG FlowScreen CT

Regulation Number: 21 CFR 868.1890

Regulation Name: Predictive Pulmonary Function Value Calculator Regulatory Class: II Product Code: BTY,DPS Dated: May 7, 2008 Received: May 12, 2008

Dear Mr. Rust:

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 device, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Page 2 - Mr. Rust

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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clare

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

510(k) Number (if known): K080734

Device Name:

FlowScreen FlowScreen ECG FlowScreen CT

Indications for Use:

The FlowScreen / FlowScreen ECG is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).

In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. 12channel ECGs are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.

The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.

The FlowScreen is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.

Federal U.S. law restricts this device to sale by or on the order of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

NEEDED)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K080734

Page 1 of