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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 K861544
Device Name MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM
Applicant
HEWLETT-PACKARD CO.
SCHUCKARDSTRABE 4
7030 BOBLINGEN
GERMANY,  DE
Applicant Contact LENKE
Correspondent
HEWLETT-PACKARD CO.
SCHUCKARDSTRABE 4
7030 BOBLINGEN
GERMANY,  DE
Correspondent Contact LENKE
Regulation Number884.2740
Classification Product Code
HGM  
Date Received04/24/1986
Decision Date 07/18/1986
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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