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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 K970098
Device Name E100 SERIES SPO2 SENSORS
Applicant
Epic Medical Equipment Services, Inc.
4643 Westgrove
Dallas,  TX  75248
Applicant Contact JEFFREY SECUNDA
Correspondent
Epic Medical Equipment Services, Inc.
4643 Westgrove
Dallas,  TX  75248
Correspondent Contact JEFFREY SECUNDA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/13/1997
Decision Date 04/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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