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FDA 510(k)

Doppler FHR Detector (BF-500D+, BF-560)

K-Number: K242846 · 2025-06-26

ApplicantShenzhen Bestman Instrument Co., Ltd.
Decision Date2025-06-26
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Doppler FHR Detector (BF-500D+, BF-560) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Bestman Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K242846. 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 FHR Detector (BF-500D+, BF-560)?

Doppler FHR Detector (BF-500D+, BF-560) is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Shenzhen Bestman Instrument Co., Ltd.. The 510(k) number is K242846.

When did Doppler FHR Detector (BF-500D+, BF-560) receive FDA 510(k) clearance?

Doppler FHR Detector (BF-500D+, BF-560) received FDA 510(k) clearance on 2025-06-26, under 510(k) number K242846.

Who is the listed applicant for Doppler FHR Detector (BF-500D+, BF-560)?

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

What is the FDA product code for Doppler FHR Detector (BF-500D+, BF-560)?

The FDA product code for Doppler FHR Detector (BF-500D+, BF-560) is KNG.

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 FactoryK233823Ultrasonic 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.K212084Fetal DopplerShenzhen Mericonn Technology 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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