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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 K931998
Device Name LCR GENERATOR
Applicant
Philips Medical Systems (Cleveland), Inc.
5500 Avion Park Dr.
Highland Heights,  OH  44143
Applicant Contact ROBERT L.TUROCY
Correspondent
Philips Medical Systems (Cleveland), Inc.
5500 Avion Park Dr.
Highland Heights,  OH  44143
Correspondent Contact ROBERT L.TUROCY
Regulation Number892.1700
Classification Product Code
IZO  
Date Received04/23/1993
Decision Date 07/27/1993
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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