MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM

System, Monitoring, Perinatal

HEWLETT-PACKARD CO.

The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Model M1310a, Series 50t Fetal Telemetry System.

Pre-market Notification Details

Device IDK942887
510k NumberK942887
Device Name:MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
ClassificationSystem, Monitoring, Perinatal
Applicant HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham,  MA  02254
ContactMonica Ferrante
CorrespondentMonica Ferrante
HEWLETT-PACKARD CO. 175 WALTHAM ST. P.O.BOX 9030 Waltham,  MA  02254
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-20
Decision Date1994-08-15

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