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Berry BM1000B

by Shanghai Berry Electronic Tech Co., Ltd.

Berry BM1000B is a Class II device made by Shanghai Berry Electronic Tech Co., Ltd., cleared under FDA 510(k) K172141 on 4 Apr 2018 and listed in FDA GUDID since 30 Jul 2026 (UDI-DI 06924054300906), 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) K172141

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 Number06924054300906 UDI-DI Date30 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172141 Date4 Apr 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172141 decided 4 Apr 2018 Active
  • FDA GUDID UDI-DI 06924054300906 listed 30 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172141
  2. Listed FDA GUDID 06924054300906

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Berry
Generic name
Pulse oximeter
Model / reference
BM1000B
Primary DI / UDI-DI
06924054300906
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DQA (Oximeter).

Other devices from Shanghai Berry Electronic Tech Co., Ltd.

See all devices from Shanghai Berry Electronic Tech Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)