510(k) K191876
K191876 is an FDA 510(k) premarket notification submitted by Cognita Labs, LLC for the device "PulmoScan". The FDA issued a decision of Substantially Equivalent on March 18, 2020. The device falls under product code PNV (Impedance Measuring Device Utilizing Oscillation Techniques), a Class II device regulated under 21 CFR 868.1840. Cognita Labs, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2020
- Date Received
- July 15, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Impedance Measuring Device Utilizing Oscillation Techniques
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type
This device measures respiratory impedance.