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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 K000831
Device Name STAT-SHELL DISPOSABLE SP02 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 Number870.2700
Classification Product Code
DQA  
Date Received03/14/2000
Decision Date 06/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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