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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 K033093
Device Name ECHOCONNEX COMMUNICATOR
Applicant
Connexmd
8536 18th Ave. NW
Seattle,  WA  98117
Applicant Contact CURTIS LEBLEU
Correspondent
Connexmd
8536 18th Ave. NW
Seattle,  WA  98117
Correspondent Contact CURTIS LEBLEU
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/29/2003
Decision Date 11/05/2003
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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