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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 K924565
Device Name SBS MODEL 1615
Applicant
Stand-By-Systems, Inc.
5301 W. Mockingbird
Dallas,  TX  75209
Applicant Contact KENNETH J PALMER
Correspondent
Stand-By-Systems, Inc.
5301 W. Mockingbird
Dallas,  TX  75209
Correspondent Contact KENNETH J PALMER
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/09/1992
Decision Date 09/09/1994
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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