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510(k) K242846

Doppler FHR Detector (BF-500D+, BF-560) by Shenzhen Bestman Instrument Co., Ltd. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2025
Date Received
September 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by Shenzhen Bestman Instrument Co., Ltd.

  • K090510 — DOPPLER FETAL HEARTBEAT RATE DETECTOR (April 29, 2010)

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