PAHI VersalVent Model V1
by Pan-America Hyperbarics, Inc.
PAHI VersalVent Model V1 is a Class II device made by Pan-America Hyperbarics, Inc., cleared under FDA 510(k) K122560 on 26 Mar 2013 and listed in FDA GUDID since 10 Oct 2015 (UDI-DI 04719872000006), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04719872000006 | Date10 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122560 | Date26 Mar 2013 | StatusActive |
Official records
- AccessGUDID record 04719872000006
- FDA 510(k) database K122560
Across registries
- FDA 510(k) K122560 decided 26 Mar 2013 Active
- FDA GUDID UDI-DI 04719872000006 listed 10 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K122560
- Listed FDA GUDID 04719872000006
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PAHI VersalVent
- Generic name
- Portable pneumatic ventilator
- Model / reference
- Model V1
- Primary DI / UDI-DI
- 04719872000006
- 510(k) Number
- FDA product code
- CBK
- GMDN term
- Portable pneumatic ventilator
- Device class
- Class II
- Regulation number
- 868.5895
- GUDID distribution status
- In Commercial Distribution
- Size
- Height — 241.3 MillimeterWidth — 203.2 MillimeterLength — 304.8 Millimeter
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