CONTEC Sonoline B

by Contec Medical Systems Co., Ltd.

CONTEC Sonoline B is a Class II device made by Contec Medical Systems Co., Ltd., cleared under FDA 510(k) K082480 on 25 Feb 2009 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 06945040100287), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06945040100287 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK082480	Date25 Feb 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 06945040100287
FDA 510(k) database 510(k) number K082480

Across registries

2 registries list this device

FDA 510(k) K082480 decided 25 Feb 2009 Active
FDA GUDID UDI-DI 06945040100287 listed 24 Sep 2016 Listed

Timeline

2 dated events

25 Feb 2009 Cleared FDA 510(k) K082480
24 Sep 2016 Listed FDA GUDID 06945040100287

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Contec
Generic name: Foetal Doppler system probe
Model / reference: Sonoline B

Primary DI / UDI-DI: 06945040100287
510(k) Number: K082480
FDA product code: KNG
GMDN term: Foetal Doppler system probe

Device class: Class II
Regulation number: 884.2660
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number

Other properties (13, all answered No)