510(k) K251086
K251086 is an FDA 510(k) premarket notification submitted by Biotab, LLC for the device "PnueAira (PNCU-01)". The FDA issued a decision of Substantially Equivalent on August 18, 2025. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2025
- Date Received
- April 9, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type