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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Hyperbaric
510(k) Number K001121
Device Name OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
Applicant
Engineered Medical Technology, Inc.
7303 Houston Hwy.
P.O. Box 1939
Victoria,  TX  77902
Applicant Contact DON SCHMIELEY
Correspondent
Engineered Medical Technology, Inc.
7303 Houston Hwy.
P.O. Box 1939
Victoria,  TX  77902
Correspondent Contact DON SCHMIELEY
Regulation Number868.5470
Classification Product Code
CBF  
Date Received04/07/2000
Decision Date 11/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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