EPIC SPO2 FINGER SENSOR, MODEL E412-20

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 Epic Spo2 Finger Sensor, Model E412-20.

Pre-market Notification Details

Device IDK002223
510k NumberK002223
Device Name:EPIC SPO2 FINGER SENSOR, MODEL E412-20
ClassificationOximeter
Applicant EPIC MEDICAL EQUIPMENT SERVICES, INC. 1800 10TH ST., SUITE 300 Plano,  TX  75074
ContactKrista Oakes
CorrespondentKrista Oakes
EPIC MEDICAL EQUIPMENT SERVICES, INC. 1800 10TH ST., SUITE 300 Plano,  TX  75074
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-24
Decision Date2000-08-22

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