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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K851031
Device Name EXPOSCOP MOBILE IMAGING SYSTEM
Applicant
Euro-Electronics, Inc.
16494 NE 27th. Pl.
Miami,  FL  33160
Applicant Contact KENNETH J FINCK
Correspondent
Euro-Electronics, Inc.
16494 NE 27th. Pl.
Miami,  FL  33160
Correspondent Contact KENNETH J FINCK
Regulation Number892.1650
Classification Product Code
JAA  
Date Received03/12/1985
Decision Date 05/28/1985
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
Recalls CDRH Recalls
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