(247 days)
NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older.
It can be used in hospitals, in the clinical setting, and at home.
The Air Next is not intended for use in an operating room.
The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
Air Next is intended to perform basic lung function and spirometry testing. It measures parameters such as the forced expiratory volume in 1 sec (FEV1) and the forced vital capacity (FVC) in a forced expiratory maneuver. These measures can be used for detection, assessment and monitoring of diseases affecting the lung function, such as bronchial Asthma, COPD and Cystic Fibrosis.
Air Next is a hand-held spirometer, weighing 75g and it is powered by 2 AAA alkaline 1.5V batteries. It consists of 3 main components: the Air Next device, the NuvoAir disposable turbine (delivered in one package) and the Air Next mobile application downloadable from Apple's and Google's Play Stores.
The provided text describes the 510(k) premarket notification for the "Air Next" diagnostic spirometer. While it extensively details the device's characteristics, comparison to a predicate device, and compliance with various standards (electrical safety, EMC, usability, biocompatibility), it does not contain a specific section detailing acceptance criteria for performance, nor a study report proving the device meets these criteria with quantitative results from a test set.
The document states that the device "Meets ATS accuracy requirements" and "Air Next complies with the currently recognized safety and EMC standards," but it does not provide the measured performance data or the specific acceptance criteria in a quantifiable table as requested.
However, based on the information provided, we can infer some criteria and the general approach:
Inferred Acceptance Criteria based on Comparison to Predicate and Standards:
The document repeatedly references compliance with ISO 26782:2009 for spirometers and the Standardization of Spirometry 2019 Update (ATS/ERS guidelines). These standards and guidelines define accuracy requirements for spirometry parameters.
From the "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE" table, we can infer the acceptance criteria are likely to match or exceed the predicate device's performance and meet the relevant standards for the following parameters:
- Volume accuracy: ±3% of reading or ±0.050 L, whichever is greater
- Flow accuracy: ±5% or 200 mL/s (likely for PEF)
- Flow resistance: <0.5 cmH2O/L/s
- Volume range: Up to 10 L
- Flow range: 0-15L/s (for Air Next, predicate 0-16 L/s)
Regarding the Study Proving Device Meets Acceptance Criteria:
The document mentions that the device "Meets ATS accuracy requirements" and "Air Next complies with the currently recognized safety and EMC standards." This implies that testing was performed against these standards. However, the specific details of the performance study (methodology, results, sample size of test set, ground truth derivation, expert involvement, etc.) are not explicitly provided in the given text.
Therefore, many parts of your request cannot be answered from the provided document.
Here's a breakdown of what can be extracted or inferred, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Inferred from Standards/Predicate) | Reported Device Performance (Implied "Meets Standards") |
|---|---|---|
| Volume Accuracy | ±3% of reading or ±0.050 L, whichever is greater (ISO 26782) | Stated: "Meets ATS accuracy requirements" |
| Flow Accuracy (PEF) | ±5% or 200 mL/s (ISO 26782) | Stated: "Meets ATS accuracy requirements" |
| Flow Resistance | <0.5 cmH2O/L/s (ISO 26782) | Implied: Meets this standard |
| Volume Range | Up to 10 L | Up to 10 L |
| Flow Range | Comparable to predicate (0-16 L/s for predicate) | 0-15 L/s |
Missing: Specific quantitative results (e.g., actual measured accuracy values, standard deviations, confidence intervals) from a dedicated performance study. The table above only re-states the specifications it claims to meet.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing would likely be bench testing against calibrated flow/volume simulators rather than human subject data for primary accuracy claims, but specifics are missing.
3. Number of Experts and Qualifications for Ground Truth:
- Not Applicable / Not Specified: For spirometers, primary accuracy testing is typically done using mechanical test lungs and known volume/flow outputs, calibrated against highly accurate reference devices, rather than human experts establishing "ground truth" for each measurement in a test set. This type of device does not involve expert interpretation of images or signals in the same way an AI-powered diagnostic device would.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Specified: Adjudication is typically for subjective expert evaluations (e.g., image review), which does not directly apply to the objective, quantitative measurements of a spirometer's mechanical accuracy.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No: The document does not describe an MRMC study. This type of study is more common for diagnostic AI systems where human reader performance is a key variable. The Air Next is a measurement device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Yes, implied for Device Accuracy: The core performance measurements (volume, flow accuracy) are inherent to the device and its algorithms, independent of human interaction beyond operating it. The device itself (Air Next) calculates the spirometry parameters (FEV1, FVC, etc.) based on the turbine's readings. The stated compliance with ISO 26782 implies standalone algorithmic performance testing.
- Missing: Details of this standalone performance test.
7. Type of Ground Truth Used:
- Inferred: Reference Standards/Calibrated Outputs: For spirometers, the ground truth is established by using highly accurate, calibrated flow and volume generators (e.g., syringes or flow controllers) that produce known, precise airflows and volumes. These are the gold standard for verifying spirometer accuracy according to ISO 26782 and ATS/ERS guidelines.
- Not: Expert consensus, pathology, or outcomes data, as these are not relevant to the primary function of a spirometer.
8. Sample Size for the Training Set:
- Not Applicable / Not Specified: This device measures physical parameters (airflow, volume) using a turbine and a digital infrared interruption sensor, not a machine learning model that requires a "training set" of data in the common sense. Its "algorithm" is a conversion from rotations to airflow. If there is any internal calibration or minor adjustment based on manufacturing tolerances, it would be done during production, not through a "training set" in the AI/ML context.
9. How Ground Truth for the Training Set Was Established:
- Not Applicable / Not Specified: As explained above, there's no "training set" in the typical AI/ML sense for this device. The physical principle of operation and conversion algorithms are based on established physics and engineering, and then verified against calibrated standards.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 18, 2024
NuvoAir AB Daniel Keenan Senior Product Director, Medical Device 17D Riddargatan Stockholm. SE 11457 Stockholm, 11457 Sweden
Re: K231416
Trade/Device Name: Air Next Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II Product Code: BZG Dated: December 11, 2023 Received: December 11, 2023
Dear Daniel Keenan:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia,
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Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231416
Device Name Air Next
Indications for Use (Describe)
NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older.
It can be used in hospitals, in the clinical setting, and at home.
The Air Next is not intended for use in an operating room.
The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date of SummaryPreparation: | January 18, 2024 |
|---|---|
| 510(k) submitter &owner | NuvoAir AB17D RiddargatanStockholm, SE11457 |
| Contact person | Owner & contact for 510(k) submission:Furat Shawki- General Manager, CTfurat.shawki@nuvoair.com(+44)755 188 3598 |
| Common name of thedevice | Spirometer |
| Trade name | Air Next |
| Model number | NVD-02 |
| Classification | Class II Device |
| Classification name | Diagnostic Spirometer |
| Product code | BZG |
| Review panel | Anesthesiology |
| Regulation number | 21 CFR 868.1840 |
| Predicate device | |
| 510(k) number | K072979 |
| Trade name | Spirobank G |
| Product code | BZG |
| Manufacturer | MIR Medical International Research |
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Device Description
Air Next is intended to perform basic lung function and spirometry testing. It measures parameters such as the forced expiratory volume in 1 sec (FEV1) and the forced vital capacity (FVC) in a forced expiratory maneuver. These measures can be used for detection, assessment and monitoring of diseases affecting the lung function, such as bronchial Asthma, COPD and Cystic Fibrosis.
Air Next is a hand-held spirometer, weighing 75g and it is powered by 2 AAA alkaline 1.5V batteries. It consists of 3 main components: the Air Next device, the NuvoAir disposable turbine (delivered in one package) and the Air Next mobile application downloadable from Apple's and Google's Play Stores.
Indications For Use
NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older.
It can be used in hospitals, in the clinical settings, and at home.
The Air Next is not intended for use in an operating room.
The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
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| Predicate | K Number | Brand Name | CE Certificate | Company |
|---|---|---|---|---|
| Primary | K072979 | Spirobank G | 93/42/EEC CertifiedNo: MED 9826 | MIR Medical InternationalResearch |
| Reference | K061712 | Spirobank II | NoBo:0476Valid until: 2023-02-04 | MIR Medical InternationalResearch |
| Product Code | BZG | Regulation No | 21 CFR 868.1840 |
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE
| Characteristics | NuvoAirAir Next | Spirobank GK072979 | notes |
|---|---|---|---|
| Manufacturer | NuvoAir | MIR MedicalInternational Research | |
| RegulationNumber | 21 CFR 868.1840 | 21 CFR 868.1840 | Same |
| Product Code | BZG | BZG | Same |
| Indications for Use | NuvoAir Air Next isintended to test lungfunction andspirometry in adultsand children 5 years ofage and older.It can be used inhospitals, in the clinicalsetting, and at home.The Air Next is notintended for use in anoperating room.The user is notintended to interpret ortake clinical actionbased on the deviceoutput withoutconsultation of aqualified healthcareprofessional. | The Spirobank Gspirometer is intended tobe used by a physician orby a patient under theinstruction of a physicianor paramedic.The device is intended to testlung function and canmake spirometry testingin people of all ages,excluding infants andneonates.It can be used in anysetting. | Similar |
| Type of Use | Prescription Use | Prescription Use | Same |
| User Environment | Hospitals, in theclinical setting, and athome. | In any setting | The use environmentfor the subject device isa subset of thepredicate device useenvironment. |
| Principle ofOperation | The Air Next is designedto work with NuvoAirdisposable turbine. Whenperforming a spirometrytest, the user exhales intothe turbine. The airflowgenerated is forcing apropeller to rotate insidethe turbine. The Air Nextregisters the speed of thespinning propeller bycounting the rotationswith a digital infraredinterruption sensor. Thealgorithm in the firmwareinside the Air Nextdevice then converts therotations into airflowmeasured in liters persecond.This widely spreadtechnology circumventsthe need for individualcalibration by exploitingmechanical properties ofthe turbine, which areverified and calibrated atthe time of | Spirobank G is a powerfuland compact measurementdevice, intended for use bya respiratory specialist orby a suitably trainedgeneralist.Two different types ofturbine sensors can beused with the device, oneis reusable and one issingle-patient disposable. Adisposable mouthpiece isrequired in order toconnect a subjectto the spirometer.The flow and volumemeasurement sensor is adigital turbine, based on theinfrared interruption principal.Cleaning of the disposableturbine is not required, as itis supplied clean in a sealedplastic bag. It must bedisposed of after use. | Substantiallyequivalent (SE)Differences do notraise new ordifferent questionsof safety oreffectiveness |
| Flow Sensor | Bidirectional turbinewith infraredinterruption | Bidirectional turbinewith infraredinterruption | Same |
| Energy Type | Two AAA 1.5VAlkaline | 9V Alkaline battery | SE |
| batteries | |||
| Display | Touchscreen onsmartphone ortablet | Touchscreen / LCD andmembrane keys128 x 48 pixel, graphicLCD - FSTN | Similar |
| OperatingEnvironment | T: min $+10$ °C/max$+40$ ° C RH: min 10%/max 95 % ALT:max 2000 m | Temperature: MIN $+ 10$°C, MAX $+ 40$ °C;Humidity: MIN 10% RH;MAX 95%RH | Same |
| Physical Size | Light hand-held device | Light hand-held device | Same |
| Weight | 75g | 160g | Differences do not raisenew or differentquestions of safetyand effectiveness |
| Volume accuracy | ±3% of reading or$±0.050$ L,whichever isgreater | ±3% of reading or$±0.050$ L, whichever isgreater | Same |
| Volume range | Up to 10L | Up to 10 L | Same |
| Flow range | 0-15L/s | 0-16 L/s | Similar |
| Flow accuracy | ±5% or 200 mL/s | ±5% or 200 mL/s | Same |
| Flow resistance | <0.5 cmH2O/L/s | <0.5 cmH2O/L/s | Same |
| Characteristics | NuvoAirAir Next | Spirobank GK072979 | notes |
| Connectivity | Bluetooth | Bluetooth or USB | Same-Bluetooth |
| Forced vitalcapacity | FVC | FVC | Same |
| Volume expiredin the first0.75sec, 1sec,3sec, 6sec | FEV0.75, FEV1, FEV3,FEV6 | FEV0.75,FEV1,FEV3,FEV6 | Same |
| betweenRatiovolume expiredin a certain timeperiod and FVC | FEV/FVC (FER) for 0.75/1 /3 / 6 | FEV/FVC (FER) for 0.75/1 /3 / 6 | Same |
| Peak expiratoryflow | PEF | PEF | Same |
| Forced expiratoryflow between thefirst 25% and 75%of the FVC | FEF25-75 (MEF) | FEF25-75 (MEF) | Same |
| Volume inspiredin the first secondof the test | FIV 1 | FIV 1 | Same |
| Forcedinspiratoryvolume | FIVC | FIVC | Same |
| Peak inspiratoryflow | PIF | PIF | Same |
| Forced inspiratoryflow in the first25% and 75% ofthe FIV | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | Same |
| Ratio betweenFEV1 and FEV6 | FEV1/FEV6 | FEV1/FEV6 | Same |
| Forced expiratoryflow at 50% ofFVC divided byFVC | FEF50/FVC | FEF50/FVC | Same |
| Characteristics | NuvoAirAir Next | Spirobank GK072979 | notes |
| Forced inspiratoryflow in the first25% and 75% ofthe FIV | FIF25-75 (MIF25-75) | FIF25-75 (MIF25-75) | Same |
| Ratio betweenFEV1 and FEV6 | FEV1/FEV6 | FEV1/FEV6 | Same |
| Forced expiratoryflow at 50% ofFVC divided byFVC | FEF50/FVC | FEF50/FVC | Same |
| Force inspiratoryflow at first seconddevice forcedinspiratory volume | FIV1/FIVC (FIR) | FIV1/FIVC (FIR) | Same |
| Forcedexpiratorytime | FET | FET | Same |
| Maximumvoluntaryventilation | N/A | MVV (ind) | Differentbutthedifference doesnotaffect safetyoreffectiveness |
| Used with PFTfilter and / ormouthpiece | Mouthpiece Disposable | Mouthpiece Disposableor Reusable | Same forDisposable TurbineSee referencepredicate chartbelow |
| Coaching | Display of volume-time and flow-volumecurves, timer andeffort during test | Display of volume-time and flow-volume curves | The main difference isthat in the subjectdevice the user canobserve a real-timefeedback on the effortof the spirometry test,while this feature ismissing on thepredicate device. Thisdifference does notraise new or differentquestions of safety or |
| effectiveness | |||
| Feedback on testquality | Yes - according toATS 2019guidelines | Yes - Traffic lights forinterpretation | This difference doesnot raise new ordifferent questions ofsafety or effectiveness |
| Graphic display | Yes- on App | Yes on device screen | Differentbutthedifference doesnotaffect safetyandeffectiveness |
| Meets ATSaccuracyrequirements | Yes | Yes | Same |
| Applied Standardsfor safety | Electrical SafetyStandard IEC60601-1ElectroMagneticCompatibilityIEC 60601-1-2 | Electrical SafetyStandard IEC60601-1Electro MagneticCompatibility IEC 60601-1-2 | Same |
| Water ingressprotection | IP32 | IPX1 | SE |
| Biologicalcharacteristics | NuvoAirAir Next | Spirobank GK072979 | Identifieddifferences |
| Uses the samematerials orsubstances incontact with thesame humantissues or bodyfluids andleachables | Plastic Covers: ABS-PC body contact: handheld | Plastic Covers: ABS-PC body contact: handheld | Same |
| Similar kind andduration ofcontact with thesame humantissues or body | surface medical device, incontact withintactskin | surface medical device, incontact withintact skin | Same |
| fluids | |||
| Similar releasecharacteristics ofsubstancesincludingdegradationproducts | limited contactduration | limited contact duration | Same |
| Biocompatibility | According to ISO 10993-1 | According to ISO 10993-1 | Same |
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● Turbine:
The disposable turbine used in the reference predicate device (K061712) is the same as the disposable used in the subject device.
Compliance with Standards ●
Air Next complies with the currently recognized safety and EMC standards:
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 -- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- · IEC 62366:2007 Medical devices Application of usability engineering to medical devices
- · 60601-1-2:2014 (ED. 4) Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- · ETSI's EN 300 328 v.1.9.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
- · FCC Part 15, Subpart B, C Unintentional Radiators, Intentional Radiators
- · Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement
- · ISO 23747:2015 -- Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
- · ISO26782:2009 -- Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans
- · IEC 60601-1-11:2015 Medical Electrical Equipment-Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-6:2010 + A1:2013. Medical electrical equipment-Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- · ISO 62304:2006/A1:2015: Medical device software. Software life cycle processes
- · ISO 14971:2007. Application of risk management to medical devices
- ISO 15223-1:2021 Medical devices Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements
- ISO 20417:2021 Medical devices Information to be supplied by the manufacturer
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Biocompatibility
Handle and Exterior Surface
The Handle and Exterior is designed to be a surface device for intact skin with limited contact A - limited (<24h). The following testing was performed:
Based on the device categorization outlined above, the nature of the material contact and the guidance given in ISO 10993-1, the tests deemed appropriate for the device materials were selected as shown in the table below.
| Biological Effect | Test | ComplianceStandard |
|---|---|---|
| Cytotoxicity | Mem Elution | ISO10993-5 |
| Irritation or IntracutaneousReactivity | Intracutaneous Injection Test | ISO10993-10 |
| Irritation and Sensitization | Kligman Maximization test | ISO10993-10 |
Substantial Equivalence Conclusion
Based upon the foregoing performance testing and comparison to the legally marketed predicate devices for indications for use, technology, and performance the Air Next is substantially equivalent and as safe and as effective as the predicate device.
§ 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).