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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K960198
Device Name DIGISCOPE RX-2
Applicant
Medirex, Inc.
831 Beacon St.
Suite 227, Box 9100
Newtown,  MA  02159
Applicant Contact AHAVA STEIN
Correspondent
Medirex, Inc.
831 Beacon St.
Suite 227, Box 9100
Newtown,  MA  02159
Correspondent Contact AHAVA STEIN
Regulation Number892.1650
Classification Product Code
OXO  
Date Received01/16/1996
Decision Date 03/12/1996
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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