The Spiro-Master PC-10 Spirometry System is intended to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate pulmonary function These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases The spirometer should only be used with pattents able to understand the instructions for performing the test

The Spiro-Master PC-10 Spirometry System is indicated for use with people of all ages, of either gender, excluding infants and neonates, to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate, access, describe, measure, or monitor

Symptoms, signs, or abnormal laboratory tests 1
Effects of disease on pulmonary function 2
3 Individuals at risk for pulmonary disease
4 Preoperative risk
5 Post-surgical prognosis
ર્ભ Pre-treatment health status
7 Therapeutic interventions
8 The course of disease affecting lung function
9 Persons exposed to pollutants
Adverse reactions to drugs with known pulmonary toxicity 10
Rehabilitation programs 11
Risks as part of an insurance evaluation 12
Individuals for legal reasons 13
14 Epidemiological surveys
Derivation of reference equations । રે

Device Description

The "Spiro-Master PC-10 Spirometry System" is a handheld spirometer that connects to a Personal Computer (PC) via a Universal Serial Bus (USB 11 and 20) cable Windows 10-based software on the PC runs the diagnostic spirometer application

The device consists of a plastic handle which houses the amplified pressure transducer, analog to digital converter. USB microcontroller and connection via a USB cable The electronics in the handle are powered by the 5 volts DC of the PC USB port The top of the handle has a connection for the flow sensor, which connects to the mouthpiece

A Pneumotach sensor is incorporated into the Spiro-Master PC-10 Spirometry System to detect arrilow The flow sensor consists of two flow tubes that connect to each other around a sensor mesh ring which provides flow resistance A differential pressure across the mesh is generated depending on the inhalation/exhalation strength of the person being tested Inside the flow tube, the front and back of the mesh is connected to a pressure sensor through pressure outlet ports and tubes This differential pressure transducer measures the pressure difference across the flow sensor (mesh ring) as the air-stream passes through it The resulting pressure change is converted to a signal proportional to the airflow rate

The patient places their mouth on the mouthpiece, which is connected to a bacterial filter (KoKo Moe White Filter) between the mouthpiece and the sensor The mouthpiece is a single-use, disposable component.

The patient breathes as instructed through the mouthpiece The pressure transducer in the handle continuously transmits the differential pressure in the flow tube to the analog to digital converter The digitized 12 bit data is sent to the PC via the USB cable at 12 bit samples per second The Spiro-Master PC-10 Spirometry System application software (which requires Windows 98 or later), calculates the flow and integrates the flow to calculate volume The flows are calculated from the 12 bit data stream by applying a calıbration polynomial algorithm All flow and volume data are calculated in real tıme for the flow-volume measurements which includes Peak Flow, Forced Vital Capacity, Forced Expiratory Flows Forced Inspiratory Vital Capacity as well as FEF and FIVC

The spirometer technician/operator uses the software on the PC to perform the tests The software includes a number of screens and 'buttons' that assust to logically perform the tests in the correct order The tests can be saved to the PC hard drive, printed (report format) and recalled for later review There are various parameters that are displayed to assust the technician in the quality control of the test procedure per the ATS 1994 update and the ATS 2005 standards The system calıbration procedure requires sıx (6) varyıng strokes from a three (3) liter syringe

AI/ML Overview

The provided document is a 510(k) summary for the Spiro-Master PC-10 Spirometry System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a standalone study proving the device meets those criteria.

Therefore, the requested information, specifically acceptance criteria and a study to prove they are met, sample sizes for test and training sets, details on ground truth establishment, expert qualifications, and MRMC study details, is not explicitly provided in this 510(k) summary.

Instead, the document states:

"As with the predicate devices, the Spiro-Master PC-10 Spirometry System has been tested for compliance to the ATS1994 (Update), IEC60601-1 and IEC60601-2 standards. In addition the Spiro-Master PC-10 Spirometry System also complies with the ATS2005 standard."
"Therefore CHEST MI, INC believes that the Spiro-Master PC-10 Spirometry System is substantially equivalent to the predicate devices and does not raise any new questions regarding safety or effectiveness."

This indicates that the device's performance is assessed against the requirements of the ATS (American Thoracic Society) standards (1994 Update and 2005) and IEC (International Electrotechnical Commission) standards (IEC60601-1 and IEC60601-2) for medical electrical equipment safety. These standards would contain the acceptance criteria for spirometry measurements. However, the summary does not detail the specific performance metrics or the study results that demonstrate compliance. It relies on the assertion of compliance with these established standards.

Without the actual study report or further supporting documentation, the specific numerical acceptance criteria and reported device performance directly from a study, the sample sizes, data provenance, ground truth establishment, and MRMC study details cannot be extracted.

Based on the available information, here's what can be inferred and what is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: The document refers to compliance with ATS 1994 (Update), ATS 2005, IEC60601-1, and IEC60601-2 standards. These standards define performance requirements for diagnostic spirometers (e.g., accuracy for FVC, FEV1, PEF measurements across specified flow/volume ranges).
Reported Device Performance: The summary states compliance but does not report specific performance values (e.g., "FVC accuracy ±3% or 50mL, whichever is greater" and then "Device achieved FVC accuracy of ±2%"). These details are typically found in the full test report, not usually in a 510(k) summary focused on substantial equivalence.

Conclusion for Table: Cannot be fully populated from the provided text as specific numerical performance results or explicit acceptance criteria specific to this device's testing are not detailed. It only states compliance with general standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The testing is implied to be against engineering/laboratory standards rather than clinical data from patients. The device calculates flow and volume from digitized pressure data, based on a calibration polynomial algorithm. Calibration involves "six (6) varying strokes from a three (3) liter syringe," which is a laboratory calibration process, not a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable in the context of this device. A diagnostic spirometer's "ground truth" for performance testing (i.e., whether it accurately measures flow and volume) is established through highly precise laboratory instruments and calibrated artificial lungs/syringes, not through human expert consensus in the way an AI diagnostic imaging device would. The calibration procedure mentions a "three (3) liter syringe," which is a standard method for establishing the known "ground truth" volume.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical evaluations, which is not described for the technical performance testing of a spirometer. The accuracy is assessed by comparing device measurements to known values from calibrated equipment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a diagnostic spirometer, which measures physiological parameters. It is not an AI-assisted diagnostic tool that would typically involve human "readers" interpreting images or complex patterns with or without AI assistance. Therefore, an MRMC study is not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, implicitly. The device's core function is to acquire, calculate, and display spirometry parameters. The compliance testing against ATS and IEC standards is essentially a standalone performance evaluation of the device's accuracy and safety, without considering human clinical interpretation improvements. The "algorithm only" performance refers to the device's ability to accurately measure and calculate flow and volume from the pressure transducer's data stream. The claim of compliance with ATS and IEC standards signifies that this standalone performance has been verified.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for performance testing is established by calibrated reference equipment, specifically a known fixed volume (e.g., from a calibrated 3-liter syringe) for volume measurements, and precise flow generators for flow accuracy. This is a laboratory-based, objective ground truth.

8. The sample size for the training set

Not applicable / Not specified. Spirometers like the Spiro-Master PC-10 typically rely on physics-based algorithms and calibration, not machine learning or AI models that require "training sets" in the conventional sense. The "calibration polynomial algorithm" is derived from physical principles and calibration procedures, not from vast datasets in anticipation of "machine learning" training.

9. How the ground truth for the training set was established

Not applicable. As explained in point 8, there isn't a "training set" in the context of AI/ML. The calibration of the device (which ensures its accuracy) is done by injecting known fixed volumes from a calibrated syringe and establishing the relationship between differential pressure and airflow/volume. This process sets the "ground truth" for the device's internal algorithms and transducers.

Summary

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510(k) Summary

a. Owner/Company name, address CHEST MI , INC

3-6-10 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan

Mr Norıo Suzukı Quality Assurance Specialist Phone 011-81-3-3812-7271 Fax 011-81-3-3812-7496 Email bck04184@nifty com

b. Contact/Application Correspondent

Fumıakı Kanaı, Ph D President and CEO MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan

011-81-3-3818-8577 Phone Fax 011-81-3-3818-8577 Email fkanaı@micinternational com

c. Date prepared

January 14, 2008

d. Name of device

Trade Name	Spiro-Master PC-10 Spirometry System
Common Name	Diagnostic spirometer
Classification Name	Diagnostic spirometer
Classification Regulation	21 CFR 868 1840

e. Predicate devices

The Spiro-Master PC-10 Sprometry System is substantially equivalent to the following legally marketed devices

510(k)	K020102
Trade name	IQTeQ Spirometer 2001
Product code	BZG
510(k)	K002499
Trade name	Brentwood IQMarkTM Digital Spirometer
Product code	BZG

SPIRO-MASTER PC-10 SPIROMETRY SYSTEM (K080921)

JAN 2 1 2009

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SPIRO-MASTER PC-10 SPIROMETRY SYSTEM PREMARKET NOTIFICATION 510(k)

f. Description of the device

Image /page/1/Picture/5 description: The image shows a laptop computer next to a piece of equipment. The equipment has a cylindrical component at the top, which is connected to a rectangular base by an arm. A cable is connected to the base of the equipment. The laptop is open and the screen is visible.

Spiro-Master PC-10 Spirometry System Figure 1

Image /page/1/Figure/8 description: The image shows a diagram of a flow sensor. The air flows through a pipe, and a flow sensor mesh ring is placed in the middle of the pipe. The pressure difference (ΔP) is measured, and the data is sent to a processor, which outputs measurement values.

Figure 2 Block diagram of air flow detection circuit

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Image /page/2/Figure/3 description: The image shows a diagram of a device with several components. The components are labeled as "Mouthpiece", "Bacterial filter", and "Sensor". An arrow shows the direction of flow from the mouthpiece to the bacterial filter and then to the sensor. A note says, "Check to be sure that the sensor is connected in the correct direction".

Figure 3 Patient connection components

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Image /page/3/Picture/35 description: The image shows a simple line drawing of a cube. The cube is drawn in a way that emphasizes its three-dimensional form. The lines are thin and black, and the background is white.

g. Intended Use, Indications for Use, and Environment

Intended Use

Indication for Use

Symptoms, signs, or abnormal laboratory tests 1
Effects of disease on pulmonary function 2
3 Individuals at risk for pulmonary disease
4 Preoperative risk
5 Post-surgical prognosis
ર્ભ Pre-treatment health status
7 Therapeutic interventions
8 The course of disease affecting lung function
9 Persons exposed to pollutants
Adverse reactions to drugs with known pulmonary toxicity 10
Rehabilitation programs 11
Risks as part of an insurance evaluation 12
Individuals for legal reasons 13
14 Epidemiological surveys
Derivation of reference equations । રે

Environment of Use

Places where a qualified cluncian desires to take lung function measurement such as in hospitals, clinics, physicians' offices, laboratories and industrial health screenings

h. Statement of substantial equivalence

The characteristics of the Spiro-Master PC-10 Spirometry System are similar to those of the predicates described in Item e above The similarities are

. same intended use
. same operating principle
same spirometry parameters �
same algorithms for spirometry parameters calculation .
same physical aspect (shape, size and weight) 0

There are no differences regarding safety or effectiveness Refer to Table 1 "Companson Table" on the following two pages for a complete assessment

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SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
PREMARKET NOTIFICATION 510(k)

	Table 1 Comparison Table
	Characteristic	IQTEQ Spirometer 2001	Predicate DevicesBrentwood IQmark™ Digital Spirometer	Spiro-Master PC-10 Spirometry System
1	PC Based	Yes	Yes	Yes
2	Physicalconfiguration	The IQTEQ Spirometer2001 is a handheldspirometer that connects to a PersonalComputer (PC) via a Universal Serial Bus(USB) port cable connection Windowsbased software on the PC runs thediagnostic spirometer application	Disposable Pneumotach Mouthpiece withhandle (containing electronics) thatconnects directly to PC serial port viacable system software disk for PCinstallation	Spiro-Master PC-10 is a handheldspirometer that connects to a PersonalComputer (PC) via a Universal SerialBus (USB) port cable connectionWindows based software on the PCruns the diagnostic spirometerapplication
3	Minimum PCrequirements	Pentium II with USB port, 128mb RAM,Windows 98 Second Edition, CD-ROMdrive, mouse, and 800X600 screenresolution	Pentium 100 MHz Processor, 16MB RAM(Windows 95&98), 32MB RAM(Windows NT), 64MB RAM (Windows2000 Professional), 10MB HD space,Windows compatible printer	Windows 98, 2000, XP, VistaKeyboard, mouse, and a CD-RomdriveVGA display accommodating1024x786, 1280x1024, or higherresolutionAt least one USB port
4	Power source	Power derived from USB port	Disposable Pneumotach Mouthpiece withhandle two series AAA batteries (1 5v)inside handle	Power derived from USB port
5	ATS Spirometryperformancerecommendations	Complies (1994 Update)	Complies (1994 Update)	Complies (1994 Update)Complies (2005)
6	Crosscontaminationcontrol	Disposable mouth piece & bacterial filter	Disposable mouth piece & bacterial filter	Disposable mouth piece & bacterialfilter
7	Flow detectionprinciple	Differential pressure Laminar flowresistance element	Disposable bi-directional pressuredifferential measuring pneumotachmouthpieces for expiratory/inspiratorytesting	Reusable pressure differentialmeasuring pneumotach
8	Flowmetercalibration method	Injection of known fixed volume fromcalibrated syringe	Injection of known fixed volume fromcalibrated syringe	Injection of known fixed volume fromcalibrated syringe
9	Display & printerused	PC monitor screen (LCD/CRT) and PCprinter	PC monitor screen (CRT), alphanumericsand graphics	PC monitor screen (LCD/CRT) and PCprinter

CONFIDENTIAL

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Table 1 Comparison Table (continued)
		Predicate Devices
Characteristic	IQTEQ Spirometer 2001	Brentwood IQmark Digital Spirometer	Spiro-Master PC-10
10 Graphic output	Flow-Volume loop,Volume/Time graph,predicted curve	Flow-Volume loop, Volume-Time curve,predicted curve, pre & post bronchodilatorcomparison	Flow-Volume loop, Volume/Timegraph, predicted curve, pre & postbronchodilator comparison,bronchodilator-challenge
11 Tests performed	FVC, FIVC, PRE/POST Bronchodilator,Flow/Volume Loop, Volume/Time graph,SVC	FVC, F-V loop, MVV, VC(SVC), IVC,respiratory pattern, PRE/POSTcomparisons, bronchodilator-challenge	FVC, MVV, MV, VC(SVC),respiratory pattern, pre/postcomparisons, broncho-challenge
12 Indices calculated(bold text indicatesthat an index usedby Brentwoodspirometer is alsoused by a listedpredicate)	FVC, FEV1, FEV3, FEV6, FEV1/FVC,FEV1/FEV6, PEFR, FEF25%, FEF50%,FEF75%, FEF25-75, FEF75-85, FIVC, PIFR,FIV0.5, FIV1, FIV3, FIV1/FIVC, FIF50%,FET100%, SVC Extrapolated V%, andV(L), Peak risk time	FVC, FEV0.5, FEV10, FEV30,FEV1/FVC; FEF25-75, FEF75-85, FEF25,FEF50, FEF75, FEF200-1200, PEF, FIVC,FIF50, FEF50/FIF50, PIF, MVV, VC, VT,ERV, RR, tE, Vext, FIV0.5, FIV0.5/FIV0.5,MVT, IRV	SVC (VC), TV, FVC, FEV0.5, FEV10,FEV30, FEV60, FEV1/FVC,FEV1/SVC, MMEF, PEF, FEF25,FEF50, FEF75, FEF25-75, FEF200-1200,FET, FIVC, FIV0.5, FIV10, PIF, FIF50,FEF50/FIF50, FIF50/FEF50, MVV, RR,MV
13 Predictive modelsused (bold textindicatespredicated modelused by Brentwoodspirometer alsoused by predicate)	Crapo, ECCS, Chernisk, Morris,Knudoson1983, Hsu, Schoenberg,NHANES III 1999 (Hankınson), Plogar79	Adult Kundson 76 & 83, Crapo(ITS),ECCS 93Pediatric Plogar 71 and Knudson 76 &83u	Crapo-Hsu, ECCS, ITS, Knudson,Morrıs, Polgar, NHANES III 1999(Hankınson)

SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
(K080921)

ATTACHMENT 4
4-6 OF 4-6 OF 4-7

CONFIDENTIAI

SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
PREMARKET NOTIFICATION 510(k)

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SPIRO-MASTER PC-10 SPIROMETRY SYSTEM PREMARKET NOTIFICATION 510(k)

As with the predicate devices, the Spiro-Master PC-10 Spirometry System has been tested for compliance to the ATS1994 (Update), IEC60601-1 and IEC60601-2 standards In addition the Spiro-Master PC-10 Spirometry System also complies with the ATS2005 standard

Therefore CHEST MI, INC believes that the Spiro-Master PC-10 Spirometry System is substantially equivalent to the predicate devices and does not raise any new questions regarding safety or effectiveness

Conclusion i.

Based on the above discussion and enclosed sections regarding substantial equivalence to predicate devices. CHEST MI. INC concludes that the Spiro-Master PC-10 Spirometry System is substantially equivalent to the IQTeQ Spirometer 2001 (K020102) and the Brentwood IQMark" Digital Spirometer (K002499) and does not raise any new questions regarding safety or effectiveness

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health. The caduceus consists of a staff with two snakes coiled around it, and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Chest M I , Incorporated C/O Fumiakı Kanaı, Ph D President and Chief Executive Officer MIC International 4-1-17 Hongo Bunkyo-ku Tokyo JAPAN 113-0033

JAN 2 1 2009

Re K080921

Trade/Device Name Spiro-Master PC-10 Spirometry System Regulation Number 21 CFR 868 1840 Regulation Name Diagnostic Spirometer Regulatory Class II Product Code BZG Dated January 14, 2009 Received January 16, 2009

Dear Dr Kanaı

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 affectung 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

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Page 2 - Dr Kanaı

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 requrements, including, but not hmited 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours,

Anthony V. Arintor for

Ginette Michaud, M D Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (If known) K080921

Device Name Spiro-Master PC-10 Spirometry System

Intended Use

The Spiro-Master PC-10 Spirometry System is intended to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate pulmonary function These measures are used in the dragnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases The spirometer should only be used with patients able to understand the instructions for performing the test

Indication for Use

Symptoms, signs, or abnormal laboratory tests 1
2 Effects of disease on pulmonary function
3 Individuals at risk for pulmonary disease
4 Preoperative risk
5 Post-surgical prognosis
Pre-treatment health status 6
7 Therapeutic interventions
8 The course of disease affecting lung function
9 Persons exposed to pollutants
10 Adverse reactions to drugs with known pulmonary toxicity
Rehabilitation programs l I
12 Risks as part of an insurance evaluation
13 Individuals for legal reasons
14 Epidemiological surveys
ા ર Derivation of reference equations

Environment of Use

Places where a qualified clinician desires to take lung function measurement such as in hospitals, clinics, physicians' offices, laboratories and industrial health screenings

Image /page/9/Picture/24 description: The image shows the words "Prescription Use" followed by the text "(Per 21 CFR 801 Subpart D)". There is a large "X" marked over the words "Prescription Use". The text is in black font and is on a white background.

AND/OR

Over-the Counter Use (21 CFR 801 Subpart C)

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

A
(P

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K080921

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).