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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 K882084
Device Name GENESIS TM FETAL SYSTEM
Applicant
Pediatric Diagnostic Service
200 N. Cobb Pkwy.
Suite 128
Marietta,  GA  30062
Applicant Contact DAVID SIMIC
Correspondent
Pediatric Diagnostic Service
200 N. Cobb Pkwy.
Suite 128
Marietta,  GA  30062
Correspondent Contact DAVID SIMIC
Regulation Number884.2740
Classification Product Code
HGM  
Date Received05/18/1988
Decision Date 05/26/1989
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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