LUCAS

Compressor, Cardiac, External

JOLIFE AB

The following data is part of a premarket notification filed by Jolife Ab with the FDA for Lucas.

Pre-market Notification Details

• Device ID: K053403
• 510k Number: K053403
• Device Name: LUCAS
• Classification: Compressor, Cardiac, External
• Applicant: JOLIFE AB 555 13TH ST. NW Washington, DC 20004
• Contact: Howard Holstein
• Correspondent: Howard Holstein; JOLIFE AB 555 13TH ST. NW Washington, DC 20004
• Product Code: DRM
• CFR Regulation Number: 870.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-12-06
• Decision Date: 2006-02-01
• Summary: summary