E100 SERIES SPO2 SENSORS

Oximeter

EPIC MEDICAL EQUIPMENT SERVICES, INC.

The following data is part of a premarket notification filed by Epic Medical Equipment Services, Inc. with the FDA for E100 Series Spo2 Sensors.

Pre-market Notification Details

Device IDK970098
510k NumberK970098
Device Name:E100 SERIES SPO2 SENSORS
ClassificationOximeter
Applicant EPIC MEDICAL EQUIPMENT SERVICES, INC. 4643 WESTGROVE Dallas,  TX  75248
ContactJeffrey Secunda
CorrespondentJeffrey Secunda
EPIC MEDICAL EQUIPMENT SERVICES, INC. 4643 WESTGROVE Dallas,  TX  75248
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-13
Decision Date1998-04-30

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