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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 K915381
Device Name PORTABLE OXYGEN GENERATOR
Applicant
Aequitron Medical, Inc.
14800 28th Ave. N.
Plymouth,  MN  55447
Applicant Contact KENNETH HARLAND
Correspondent
Aequitron Medical, Inc.
14800 28th Ave. N.
Plymouth,  MN  55447
Correspondent Contact KENNETH HARLAND
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/29/1991
Decision Date 03/11/1992
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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