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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 K942887
Device Name MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
Applicant
HEWLETT-PACKARD CO.
175 WALTHAM ST.
P.O.BOX 9030
WALTHAM,  MA  02254
Applicant Contact MONICA FERRANTE
Correspondent
HEWLETT-PACKARD CO.
175 WALTHAM ST.
P.O.BOX 9030
WALTHAM,  MA  02254
Correspondent Contact MONICA FERRANTE
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/20/1994
Decision Date 08/15/1994
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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