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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K884148
Device Name DISKCAM DC 6001
Applicant
Camtronics, Ltd.
P.O. Box 307
Delafield,  WI  53018
Applicant Contact BARRY N STONE
Correspondent
Camtronics, Ltd.
P.O. Box 307
Delafield,  WI  53018
Correspondent Contact BARRY N STONE
Regulation Number892.2010
Classification Product Code
LMB  
Date Received10/03/1988
Decision Date 11/23/1988
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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