DOPPLER FETAL HEARTBEAT RATE DETECTOR— 510(k) K090510

Name: FDA 510(k) clearance K090510
Creator: U.S. Food and Drug Administration
Published: 2010-04-29

Substantially Equivalent

Shenzhen Bestman Instrument Co., Ltd.

FDA 510(k) clearance K090510 for DOPPLER FETAL HEARTBEAT RATE DETECTOR, Substantially Equivalent on 2010-04-29. Applicant: Shenzhen Bestman Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Bestman Instrument Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2009-02-26
Decision date: 2010-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangdong, CN

Download summary PDF View on FDA.gov ↗

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