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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K791035
Device Name FETASONDE FETAL ACTIVITY MONITOR
Applicant
ROCHE MEDICAL ELECTRONICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ROCHE MEDICAL ELECTRONICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/05/1979
Decision Date 09/04/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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