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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name camera, x-ray, fluorographic, cine or spot
510(k) Number K945580
Device Name DSP OPTION
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Applicant Contact ROBERT L TUROCY
Correspondent
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
HIGHLAND HEIGHTS,  OH  44143
Correspondent Contact ROBERT L TUROCY
Regulation Number892.1620
Classification Product Code
IZJ  
Date Received11/14/1994
Decision Date 01/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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