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PulmoScan

by Cognita Labs, LLC

510(k) K191876

PulmoScan is a medical device (FDA Class II; FDA product code PNV, Impedance Measuring Device Utilizing Oscillation Techniques) made by Cognita Labs, LLC, cleared under FDA 510(k) K191876 on 18 Mar 2020, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK191876 Date18 Mar 2020ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PNV
Device class
Class II
Regulation
21 CFR Part 868.1840
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K191876

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K191876
UDI-DISize and differences
PulmoScan PulmoScan-FOT
COGNITA LABS LLC
PulmoScan-FOT00860003953716 —On the market

Similar devices

Other devices filed under FDA product code PNV (Impedance Measuring Device Utilizing Oscillation Techniques).

Other devices from Cognita Labs LLC