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FDA 510(k)

DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200

K-Number: K100626 · 2010-05-21

ApplicantShenzhen Biocare Electronics Co., Ltd.
Decision Date2010-05-21
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Biocare Electronics Co., Ltd.. It received FDA 510(k) clearance on 2010-05-21 under 510(k) number K100626. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200?

DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 is a medical device that received FDA 510(k) clearance on 2010-05-21. The listed applicant is Shenzhen Biocare Electronics Co., Ltd.. The 510(k) number is K100626.

When did DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 receive FDA 510(k) clearance?

DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 received FDA 510(k) clearance on 2010-05-21, under 510(k) number K100626.

Who is the listed applicant for DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200?

The FDA 510(k) record lists Shenzhen Biocare Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200?

The FDA product code for DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 is KNG.

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Other records listing Shenzhen Biocare Electronics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123816DIGITAL ELECTROCARDIOGRAPHSK122712DIGITAL ELECTROCARDIOGRAPHK112431DIGITAL ELECTROCARDIOGRAPHK101876DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010

Related Devices (Code: KNG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic FactoryK242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd.K233823Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd.K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)Contec Medical Systems Co.,LtdK220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,LtdK211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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