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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 K024197
Device Name LIFEDOP DOPPLER
Applicant
SUMMIT DOPPLER SYSTEMS, INC.
5350 VIVIAN ST., SUITE A
ARVADA,  CO  80002 -1957
Applicant Contact KEN JARRELL
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Regulation Number884.2660
Classification Product Code
KNG  
Subsequent Product Code
HEP  
Date Received12/20/2002
Decision Date 01/03/2003
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
Recalls CDRH Recalls
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