DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200— 510(k) K100626

Name: FDA 510(k) clearance K100626
Creator: U.S. Food and Drug Administration
Published: 2010-05-21

Substantially Equivalent

Shenzhen Biocare Electronics Co., Ltd.

FDA 510(k) clearance K100626 for DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200, Substantially Equivalent on 2010-05-21. Applicant: Shenzhen Biocare Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Biocare Electronics Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2010-03-05
Decision date: 2010-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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