K251086

Substantially Equivalent

PnueAira (PNCU-01)

Applicant: Biotab, LLC
Product 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

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