Doppler FHR Detector (BF-500D+, BF-560)— 510(k) K242846

Name: FDA 510(k) clearance K242846
Creator: U.S. Food and Drug Administration
Published: 2025-06-26

Substantially Equivalent

Shenzhen Bestman Instrument Co., Ltd.

FDA 510(k) clearance K242846 for Doppler FHR Detector (BF-500D+, BF-560), Substantially Equivalent on 2025-06-26. Applicant: Shenzhen Bestman Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Bestman Instrument Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2024-09-20
Decision date: 2025-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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