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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K990082
Device Name EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
Applicant
Epic Medical Equipment Services, Inc.
1800 10th St., Suite 300
Plano,  TX  75074
Applicant Contact JEFFREY SECUNDA
Correspondent
Epic Medical Equipment Services, Inc.
1800 10th St., Suite 300
Plano,  TX  75074
Correspondent Contact JEFFREY SECUNDA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/11/1999
Decision Date 04/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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