Penlon 54909
by Penlon, Ltd.
Penlon 54909 is a Class II device made by Penlon, Ltd., cleared under FDA 510(k) K961468 on 16 Jul 1996 and listed in FDA GUDID since 21 Jun 2023 (UDI-DI 05051977001595), 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 | Number05051977001595 | Date21 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK961468 | Date16 Jul 1996 | StatusActive |
Official records
- AccessGUDID record 05051977001595
- FDA 510(k) database K961468
Across registries
- FDA 510(k) K961468 decided 16 Jul 1996 Active
- FDA GUDID UDI-DI 05051977001595 listed 21 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K961468
- Listed FDA GUDID 05051977001595
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Penlon
- Generic name
- Sevoflurane anaesthesia vaporizer
- Model / Ref / Catalog
- 54909
- Primary DI / UDI-DI
- 05051977001595
- 510(k) Number
- FDA product code
- CAD
- GMDN term
- Sevoflurane anaesthesia vaporizer
- Device class
- Class II
- Regulation number
- 868.5880
- GUDID distribution status
- In Commercial Distribution
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