WINDSURFER

Computer, Diagnostic, Programmable

MEDCON LTD.

The following data is part of a premarket notification filed by Medcon Ltd. with the FDA for Windsurfer.

Pre-market Notification Details

• Device ID: K050561
• 510k Number: K050561
• Device Name: WINDSURFER
• Classification: Computer, Diagnostic, Programmable
• Applicant: MEDCON LTD. POB 6718 Efrat, IL 90435
• Contact: Eli M Orbach
• Correspondent: Eli M Orbach; MEDCON LTD. POB 6718 Efrat, IL 90435
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-03
• Decision Date: 2005-05-04
• Summary: summary