PulmoScan— 510(k) K191876

Substantially Equivalent

Cognita Labs, LLC

FDA 510(k) clearance K191876 for PulmoScan, Substantially Equivalent on 2020-03-18. Applicant: Cognita Labs, LLC. Device class: 2.

Clearance details

Applicant: Cognita Labs, LLC
Product code: Code PNV
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2019-07-15
Decision date: 2020-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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