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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 K992259
Device Name ECHOCARDIOGRAPHY SYSTEM SERIES 95000
Applicant
CAMTRONICS, LTD.
MEDICAL SYSTEMS
900 WALNUT RIDGE DR., BOX 950
HARTLAND,  WI  53029
Applicant Contact ROBERT KRIEDERMANN
Correspondent
CAMTRONICS, LTD.
MEDICAL SYSTEMS
900 WALNUT RIDGE DR., BOX 950
HARTLAND,  WI  53029
Correspondent Contact ROBERT KRIEDERMANN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/06/1999
Decision Date 09/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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