FDA 510(k)

도플러 FHR探测器 (BF-500D+, BF-560)

K-번호: K242846 · 2025-06-26

신청자Shenzhen Bestman Instrument Co., Ltd.

결정일2025-06-26

제품 코드KNG

자문 위원회OB

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

도플러 FHR探测器 (BF-500D+, BF-560)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: KNG)

공식 출처