K251086
- 510(k) number
- K251086
- Device name
- PnueAira (PNCU-01)
- Applicant
- Biotab, LLC MO · US
- Product code
- JOW — Sleeve, Limb, Compressible
- Decision date
- 2025-08-18
- Date received
- 2025-04-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251086.pdf
Official FDA record: K251086
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.