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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K012446
Device Name OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
Applicant
Charles A. Smith
811 Starlite Dr.
Louisville,  KY  40207
Applicant Contact CHARLES A SMITH
Correspondent
Charles A. Smith
811 Starlite Dr.
Louisville,  KY  40207
Correspondent Contact CHARLES A SMITH
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/01/2001
Decision Date 10/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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