WINDSURFER


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

Correspodent Contact eli m orbach
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 03/03/2005
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