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Epcom Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K910518GLOVE-N-GEL AMNIOTOMY KITMay 9, 1991
K905812INTRAUTERINE CATHETER SETJanuary 31, 1991
K881414CERVICATHJune 14, 1988
K871079FETALFLEX FETAL ELECTRODEJuly 13, 1987
K8443381URO-LOG HOME DIAGNOSTIC PACKFebruary 25, 1985
K844503UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACKJanuary 2, 1985
K841805OBSTETRICAL DOPPLERJune 19, 1984
K831115EPCOM EMS-320 REMOTE MONITORSCOPEAugust 12, 1983
K831114EPCOM EMS-330 FREEDOM I TELEDOP OBSTETAugust 12, 1983
K831113EPCOM EMS-310 INTRAPARTUM MONITORAugust 12, 1983
K831112EPCOM VCU-1 VACUUM SYSTEM & CURETTEJune 30, 1983
K813275EPCOM EMS SCAN IIMarch 31, 1982
K813007EPCOM EMS-180 ANTEPARTUM FETAL MONITORDecember 10, 1981