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Contec CONTEC10D

by Contec Medical Systems Co., Ltd.

Contec CONTEC10D is a Class II device made by Contec Medical Systems Co., Ltd., cleared under FDA 510(k) K232893 on 14 Jun 2024 and listed in FDA GUDID since 16 Jul 2024 (UDI-DI 06945040109914), 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) K232893

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 Number06945040109914 UDI-DI Date16 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232893 Date14 Jun 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232893 decided 14 Jun 2024 Active
  • FDA GUDID UDI-DI 06945040109914 listed 16 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232893
  2. Listed FDA GUDID 06945040109914

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Contec
Generic name
Foetal Doppler system
Model / reference
CONTEC10D
Primary DI / UDI-DI
06945040109914
510(k) Number
FDA product code
KNG
GMDN term
Foetal Doppler system
Device class
Class II
Regulation number
884.2660
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Foetal Doppler systemFoetal Doppler system probe

Cleared under the same submission (K232893)

Other devices from Contec Medical Systems Co., Ltd.

See all devices from Contec Medical Systems Co., Ltd. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)