Epic Medical Equipment Services, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K012333FLEXI-SITE SP02 EAR SENSOROctober 17, 2001
K002848SPO2 WRAP SENSORMay 24, 2001
K010718FLEXI-SITE SP02 EAR SENSORMarch 23, 2001
K002223EPIC SPO2 FINGER SENSOR, MODEL E412-20August 22, 2000
K000831STAT-SHELL DISPOSABLE SP02 SENSORJune 5, 2000
K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGJanuary 18, 2000
K992211SPO2 WRAP SENSORDecember 22, 1999
K992092STAT-SHELL DISPOSABLE SPO2 SENSORDecember 22, 1999
K990082EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09April 9, 1999
K970098E100 SERIES SPO2 SENSORSApril 30, 1998
K965172OXIMETER PRE-AMP CABLEJuly 16, 1997
K964055FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)February 21, 1997
K954168E100A PULSE OXIMETER FINGER SENSOR/PROBESeptember 12, 1996