PnueAira (PNCU-01)— 510(k) K251086

Substantially Equivalent

Biotab, LLC

FDA 510(k) clearance K251086 for PnueAira (PNCU-01), Substantially Equivalent on 2025-08-18. Applicant: Biotab, LLC.

Clearance details

Applicant: Biotab, LLC
Product code: Code JOW
Advisory panel: Cardiovascular
Date received: 2025-04-09
Decision date: 2025-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.