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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K850253
Device Name ECONO MATE -OXYGEN CONCENTRATOR
Applicant
Mountain Medical Equipment, Inc.
10488 W. Centennial Rd.
Littleton,  CO  80127
Applicant Contact JAMES W MORGAN
Correspondent
Mountain Medical Equipment, Inc.
10488 W. Centennial Rd.
Littleton,  CO  80127
Correspondent Contact JAMES W MORGAN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/22/1985
Decision Date 02/01/1985
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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