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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 K855044
Device Name PERINATAL COMPUTER SYS MODEL 100A & 100B
Applicant
Peritronics Research and Development, Inc.
P.O. Box 1117
Arcadia,  CA  91006
Applicant Contact SENG KOH
Correspondent
Peritronics Research and Development, Inc.
P.O. Box 1117
Arcadia,  CA  91006
Correspondent Contact SENG KOH
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/17/1985
Decision Date 03/12/1986
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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