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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K913222
Device Name OPTIMA
Applicant
Olympic Controls Corp.
1080 E. Chicago St.
Elgin,  IL  60120
Applicant Contact JOHN SCANDORA
Correspondent
Olympic Controls Corp.
1080 E. Chicago St.
Elgin,  IL  60120
Correspondent Contact JOHN SCANDORA
Regulation Number892.1700
Classification Product Code
IZO  
Date Received07/19/1991
Decision Date 12/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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