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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, Stationary
510(k) Number K853753
Device Name DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302
Applicant
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Applicant Contact GLASSER
Correspondent
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Correspondent Contact GLASSER
Regulation Number892.1680
Classification Product Code
KPR  
Date Received09/09/1985
Decision Date 10/02/1985
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
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