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Data / Medical devices / China / Shenzhen Bestman Instrument Co.,ltd

Shenzhen Bestman Instrument Co.,ltd: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances

Shenzhen Bestman Instrument Co.,ltd is registered with the FDA (registration 3008756262) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 26, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
3008756262
Address
8th Floor, Yifang Building No.315 Shuangming Avenue, Guangming Street, Guangming District, Shenzhen Guangdong, China, 518107
Owner or operator
Shenzhen Bestman Instrument CO.,Ltd (10034759)
Roles
Exporter to the US, Manufacturer
First device listed
December 29, 2010
Registered through
2026
Brand names listed
Doppler FHR Detector, Models:BF-500B,BF-500+,and BF-500++, Trade/Device name:Doppler fetal heartbeat detector

Devices it lists

DeviceProduct codeClassRoleSource
Monitor, Ultrasonic, FetalKNG2Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 26, 2025K242846Doppler FHR Detector (BF-500D+, BF-560)KNGSubstantially EquivalentShenzhen Bestman Instrument Co., Ltd.accessdata.fda.gov
April 29, 2010K090510DOPPLER FETAL HEARTBEAT RATE DETECTORKNGSubstantially EquivalentShenzhen Bestman Instrument Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated June 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.