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Berry® BM2000A

by Shanghai Berry Electronic Tech Co., Ltd.

Berry® BM2000A is a Class II device made by Shanghai Berry Electronic Tech Co., Ltd., cleared under FDA 510(k) K142687 on 13 Apr 2015 and listed in FDA GUDID since 22 Apr 2026 (UDI-DI 06924054300586), active as of 2 Nov 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 2 Nov 2026

Documents

510(k) K142687

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06924054300586 UDI-DI Date22 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142687 Date13 Apr 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142687 decided 13 Apr 2015 Active
  • FDA GUDID UDI-DI 06924054300586 listed 22 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142687
  2. Listed FDA GUDID 06924054300586

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  • Withdrawn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
BM2000A
Primary DI / UDI-DI
06924054300586
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)