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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K090510
Device Name DOPPLER FETAL HEARTBEAT RATE DETECTOR
Applicant
Shenzhen Bestman Instrument Co., Ltd.
Keji Nan #12 Rd.
Hi-Tech Park, Shenzhen
Guangdong,  CN
Applicant Contact KATHY GUO
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number884.2660
Classification Product Code
KNG  
Date Received02/26/2009
Decision Date 04/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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