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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K941793
Device Name OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)
Applicant
Mountain Medical Equipment, Inc.
10488 W. Centennial Rd.
Littleton,  CO  80127
Applicant Contact LINDA CHAPMAN
Correspondent
Mountain Medical Equipment, Inc.
10488 W. Centennial Rd.
Littleton,  CO  80127
Correspondent Contact LINDA CHAPMAN
Regulation Number868.1720
Classification Product Code
CCL  
Date Received04/11/1994
Decision Date 06/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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