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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 K941145
Device Name OXY-GENERATOR
Applicant
Med Systems
2510 Arizona Ave. Suite 8
Santa Monica,  CA  90404
Applicant Contact JIM DAVIS
Correspondent
Med Systems
2510 Arizona Ave. Suite 8
Santa Monica,  CA  90404
Correspondent Contact JIM DAVIS
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/10/1994
Decision Date 09/27/1995
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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