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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K051649
Device Name VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0
Applicant
CAMTRONICS MEDICAL SYSTEMS
900 WALNUT RIDGE DR.
HARTLAND,  WI  53029
Applicant Contact STEVE KRUEGER
Correspondent
CAMTRONICS MEDICAL SYSTEMS
900 WALNUT RIDGE DR.
HARTLAND,  WI  53029
Correspondent Contact STEVE KRUEGER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/21/2005
Decision Date 08/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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