PnueAira (PNCU-01)— 510(k) K251086
Substantially EquivalentBiotab, LLC
FDA 510(k) clearance K251086 for PnueAira (PNCU-01), Substantially Equivalent on 2025-08-18. Applicant: Biotab, LLC. Device class: 2.
Clearance details
- Applicant
- Biotab, LLC
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code JOW
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