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510(k) K090510

DOPPLER FETAL HEARTBEAT RATE DETECTOR by Shenzhen Bestman Instrument Co., Ltd. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2010
Date Received
February 26, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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