Doppler FHR Detector (BF-500D+, BF-560)
K-Number: K242846 · 2025-06-26
Decision Date2025-06-26
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Doppler FHR Detector (BF-500D+, BF-560) is a medical device manufactured by Shenzhen Bestman Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-06-26 under approval 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. It is manufactured by Shenzhen Bestman Instrument Co., Ltd.. The 510(k) number is K242846.
When was Doppler FHR Detector (BF-500D+, BF-560) approved by the FDA?
Doppler FHR Detector (BF-500D+, BF-560) received FDA 510(k) clearance on 2025-06-26, under approval number K242846.
What company makes Doppler FHR Detector (BF-500D+, BF-560)?
Doppler FHR Detector (BF-500D+, BF-560) is manufactured by Shenzhen Bestman Instrument Co., Ltd..
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.