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Hi-bebe BT-200C

by Bistos Co., Ltd.

Hi-bebe BT-200C is a Class II device made by Bistos Co., Ltd., cleared under FDA 510(k) K052190 on 4 Oct 2005 and listed in FDA GUDID since 16 Mar 2018 (UDI-DI 00887529000199), 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) K052190

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 Number00887529000199 UDI-DI Date16 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052190 Date4 Oct 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052190 decided 4 Oct 2005 Active
  • FDA GUDID UDI-DI 00887529000199 listed 16 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K052190
  2. Listed FDA GUDID 00887529000199

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hi-bebe
Generic name
Foetal Doppler system
Model / reference
BT-200C
Primary DI / UDI-DI
00887529000199
510(k) Number
FDA product code
HGM
GMDN term
Foetal Doppler system
Device class
Class II
Regulation number
884.2740
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Foetal Doppler systemFoetal Doppler system probe

Cleared under the same submission (K052190)

Other devices from Bistos Co., Ltd.

See all devices from Bistos Co., Ltd. →

Properties

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