FC700

by Bionet Co., Ltd.

FC700 is a Class II device made by Bionet Co., Ltd., cleared under FDA 510(k) K043597 on 16 Dec 2005 and listed in FDA GUDID since 15 Jul 2021 (UDI-DI 08809276943590), active as of 12 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 12 Nov 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08809276943590 UDI-DI	Date15 Jul 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK043597	Date16 Dec 2005Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08809276943590
FDA 510(k) database 510(k) number K043597

Across registries

2 registries list this device

FDA 510(k) K043597 decided 16 Dec 2005 Active
FDA GUDID UDI-DI 08809276943590 listed 15 Jul 2021 Listed

Timeline

2 dated events

16 Dec 2005 Cleared FDA 510(k) K043597
15 Jul 2021 Listed FDA GUDID 08809276943590

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Foetal cardiac monitor
Model / reference: FC700

Primary DI / UDI-DI: 08809276943590
510(k) Number: K043597
FDA product code: HGM
GMDN term: Foetal cardiac monitor

Device class: Class II
Regulation number: 884.2740
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

Other devices from Bionet Co., Ltd.

See all devices from Bionet Co., Ltd. →

Properties

Serial number
Manufacturing date

Other properties (13, all answered No)