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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter, ear
510(k) Number K012333
Device Name FLEXI-SITE SP02 EAR SENSOR
Applicant
EPIC MEDICAL EQUIPMENT SERVICES, INC.
1800 10TH ST., SUITE 300
PLANO,  TX  75074
Applicant Contact KRISTA OAKES
Correspondent
EPIC MEDICAL EQUIPMENT SERVICES, INC.
1800 10TH ST., SUITE 300
PLANO,  TX  75074
Correspondent Contact KRISTA OAKES
Regulation Number870.2710
Classification Product Code
DPZ  
Date Received07/24/2001
Decision Date 10/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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