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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 K915138
Device Name GE SONOCHROME
Applicant
GE MEDICAL SYSTEMS
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact LARRY KRAGER
Correspondent
GE MEDICAL SYSTEMS
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact LARRY KRAGER
Regulation Number884.2660
Classification Product Code
MAA  
Date Received11/13/1991
Decision Date 10/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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