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Personal Best 00

by Respironics Respiratory Drug Delivery (UK) Ltd 9 variants

Personal Best 00 (1023870) is a peak flow meter (FDA Class II; FDA product code BZH, Meter, Peak Flow, Spirometry) made by Respironics Respiratory Drug Delivery (UK) Ltd, cleared under FDA 510(k) K933889 on 9 Sep 1993 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 00383730000466), 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) K933889

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 Number00383730000466 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK933889 Date9 Sep 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K933889 decided 9 Sep 1993 Active
  • FDA GUDID UDI-DI 00383730000466 listed 24 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K933889
  2. Listed FDA GUDID 00383730000466

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Personal Best
Generic name
Peak flow meter, manual
Model / Ref / Catalog
00, 1023870
Primary DI / UDI-DI
00383730000466
510(k) Number
FDA product code
BZH
GMDN term
Peak flow meter, manual
Device class
Class II
Regulation number
868.1860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Peak flow meter, manual

Cleared under the same submission (K933889)

Other devices from Respironics Respiratory Drug Delivery (UK) Ltd

See all devices from Respironics Respiratory Drug Delivery (UK) Ltd →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)