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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Fetal Doppler Ultrasound
510(k) Number K102138
Device Name ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER
Applicant
Edan Instruments, Inc.
3/F-B, Nanshan Medical
Equipment Park, Nanhai Rd. 1019
Shenzhen,  CN 518067
Applicant Contact LIU YONGYING
Correspondent
Edan Instruments, Inc.
3/F-B, Nanshan Medical
Equipment Park, Nanhai Rd. 1019
Shenzhen,  CN 518067
Correspondent Contact LIU YONGYING
Regulation Number884.2660
Classification Product Code
MAA  
Subsequent Product Code
JAF  
Date Received07/30/2010
Decision Date 10/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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