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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 K870692
Device Name PERINATAL COMPUTERS 2015/2025/2040/2045/2080/2085
Applicant
PERITRONICS RESEARCH AND DEVELOPMENT, INC.
P.O. BOX 1117
ARCADIA,  CA  91006
Applicant Contact KOH, MD
Correspondent
PERITRONICS RESEARCH AND DEVELOPMENT, INC.
P.O. BOX 1117
ARCADIA,  CA  91006
Correspondent Contact KOH, MD
Regulation Number884.2740
Classification Product Code
HGM  
Date Received02/19/1987
Decision Date 05/04/1987
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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