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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K050561
Device Name WINDSURFER
Applicant
MEDCON LTD.
POB 6718
EFRAT,  IL 90435
Applicant Contact ELI M ORBACH
Correspondent
MEDCON LTD.
POB 6718
EFRAT,  IL 90435
Correspondent Contact ELI M ORBACH
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/03/2005
Decision Date 05/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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