Pfm 4300
by Vitalograph Ireland, Ltd. 8 variants
Pfm 4300 is a Class I device made by Vitalograph Ireland, Ltd., cleared under FDA 510(k) K781922 on 13 Feb 1979 and listed in FDA GUDID since 6 Dec 2016 (UDI-DI 05099169439009), 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 | Number05099169439009 | Date6 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK781922 | Date13 Feb 1979 | StatusActive |
Official records
- AccessGUDID record 05099169439009
- FDA 510(k) database K781922
Across registries
- FDA 510(k) K781922 decided 13 Feb 1979 Active
- FDA GUDID UDI-DI 05099169439009 listed 6 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K781922
- Listed FDA GUDID 05099169439009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pfm
- Generic name
- Expiratory peak flow meter, analogue, reusable
- Model / reference
- 4300
- Primary DI / UDI-DI
- 05099169439009
- 510(k) Number
- FDA product code
- BXW
- GMDN term
- Expiratory peak flow meter, analogue, reusable
- Device class
- Class I
- Regulation number
- 868.1870
- GUDID distribution status
- In Commercial Distribution
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