Pfm 4300
by Vitalograph Ireland, Ltd. 7 variants
Pfm 4300 is a Class II device made by Vitalograph Ireland, Ltd., cleared under FDA 510(k) K781922 on 13 Feb 1979 and listed in FDA GUDID since 1 Dec 2016 (UDI-DI 05099169436022), 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 | Number05099169436022 | Date1 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK781922 | Date13 Feb 1979 | StatusActive |
Official records
- AccessGUDID record 05099169436022
- FDA 510(k) database K781922
Across registries
- FDA 510(k) K781922 decided 13 Feb 1979 Active
- FDA GUDID UDI-DI 05099169436022 listed 1 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K781922
- Listed FDA GUDID 05099169436022
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- Withdrawn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
- 05099169436022
- 510(k) Number
- FDA product code
- BZH
- GMDN term
- Expiratory peak flow meter, analogue, reusable
- Device class
- Class II
- Regulation number
- 868.1860
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code BZH (METER, PEAK FLOW, SPIROMETRY).
- PEAKLOG AND DISPLAY SOFTWARE by Medtrac Technologies Corp.
- MODIFIED ASSESS(R) PEAK FLOW METER by Health Products, Inc.
- KOKO PEAK KP; KOKO PEAK KP+ by Pds Healthcare Products, Inc.
- GALEMED PEAK FLOW METER, MODELS 3751/3752 by Galemed Corp.
- METER, FLOW, PEAK by Projects IN Health
- VMX MINI-LOG FLOWMETER by Clement Clarke, Inc.
- TD-7301 Peak Flow meter by Gostar Co., Ltd.
- Airzone 3130045ATM by CLEMENT CLARKE INTERNATIONAL LIMITED
- Wing Smart FEVI and Peak Flow Meter by Sparo, Inc.