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Mini Wright 3104330S

by Clement Clarke International Limited

Mini Wright 3104330S is a peak flow meter (FDA Class II; FDA product code BZH, Meter, Peak Flow, Spirometry) made by Clement Clarke International Limited, cleared under FDA 510(k) K952713 on 29 Mar 1996 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 05023323001474), active as of 22 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 22 Oct 2026

Documents

510(k) K952713

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05023323001474 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK952713 Date29 Mar 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K952713 decided 29 Mar 1996 Active
  • FDA GUDID UDI-DI 05023323001474 listed 7 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K952713
  2. Listed FDA GUDID 05023323001474

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mini Wright
Generic name
Peak flow meter, manual
Model / Ref / Catalog
3104330S
Primary DI / UDI-DI
05023323001474
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

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Properties

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