Atlas FDA

PNV

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Impedance Measuring Device Utilizing Oscillation Techniques
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1840
Medical specialty
Anesthesiology
FDA definition
This device measures respiratory impedance.
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RecordFirmDate
tremoflo C2 Airwave Oscillometry System (K221024)Thorasys Thoracic Medical Systems, Inc.2023-06-20
PulmoScan (K191876)Cognita Labs, LLC2020-03-18
tremoFlo C-100 Airwave Oscillometry System (K170185)Thorasys Thoracic Medical Systems, Inc.2017-09-12
Resmon PRO FULL (K152585)Medical Graphics Corp.2016-06-24

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Every clearance here is in the API, with alerts when new ones post.