Thermofinder S FS-700pro

by HuBDIC Co., Ltd.

Thermofinder S FS-700pro is a Class II device made by HuBDIC Co., Ltd., cleared under FDA 510(k) K130361 on 2 Apr 2013 and listed in FDA GUDID since 13 Apr 2022 (UDI-DI 08800132200246), active as of 23 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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08800132200246 UDI-DI	Date13 Apr 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK130361	Date2 Apr 2013Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08800132200246
FDA 510(k) database 510(k) number K130361

Across registries

2 registries list this device

FDA 510(k) K130361 decided 2 Apr 2013 Active
FDA GUDID UDI-DI 08800132200246 listed 13 Apr 2022 Listed

Timeline

2 dated events

2 Apr 2013 Cleared FDA 510(k) K130361
13 Apr 2022 Listed FDA GUDID 08800132200246

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Thermofinder S
Generic name: Infrared patient thermometer, skin
Model / reference: FS-700pro

Primary DI / UDI-DI: 08800132200246
510(k) Number: K130361
FDA product code: FLL
GMDN term: Infrared patient thermometer, skin

Device class: Class II
Regulation number: 880.2910
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Infrared patient thermometer, skin.

Other devices from HuBDIC Co., Ltd.

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Properties

Over-the-counter
Lot / batch number
Serial number
Manufacturing date

Other properties (11, all answered No)