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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Pressure, Intrauterine
510(k) Number K780487
Device Name FETAL MONITORING SYSTEM
Applicant
Sonicaid, Inc.
VA 
Correspondent
Sonicaid, Inc.
VA 
Regulation Number884.2700
Classification Product Code
HFO  
Date Received03/27/1978
Decision Date 05/09/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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