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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Heart Sound, Fetal, Ultrasonic
510(k) Number K060410
Device Name ECHOHEART TRANSVAGINAL DOPPLER PROBE
Applicant
Summit Doppler Systems, Inc.
4620 Technology Dr. Unit 100
Golden,  CO  80403
Applicant Contact KEN JARRELL
Correspondent
Summit Doppler Systems, Inc.
4620 Technology Dr. Unit 100
Golden,  CO  80403
Correspondent Contact KEN JARRELL
Regulation Number884.2660
Classification Product Code
HEK  
Subsequent Product Code
ITX  
Date Received02/16/2006
Decision Date 04/10/2006
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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