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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 K884563
Device Name OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3%
Applicant
Ivex Medical, Inc.
P.O. Box 797
Englewood,  CO  80151
Applicant Contact NORBERT VOGLER
Correspondent
Ivex Medical, Inc.
P.O. Box 797
Englewood,  CO  80151
Correspondent Contact NORBERT VOGLER
Regulation Number868.5440
Classification Product Code
CAW  
Date Received10/31/1988
Decision Date 04/26/1989
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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