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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 United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K781922

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05099169436022 UDI-DI Date1 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK781922 Date13 Feb 1979DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K781922 decided 13 Feb 1979 Active
  • FDA GUDID UDI-DI 05099169436022 listed 1 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K781922
  2. Listed FDA GUDID 05099169436022

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

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).

Other devices from Vitalograph Ireland, Ltd.

  • comPAS2 2025.1.0

    Class II
  • Bvf 2820

    Class II
  • Pft 2820

    Class II
  • Pfm 4300

    Class II

See all devices from Vitalograph Ireland, Ltd. →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)