CARDNAV

Interventional Fluoroscopic X-ray System

PAIEON, INC.

The following data is part of a premarket notification filed by Paieon, Inc. with the FDA for Cardnav.

Pre-market Notification Details

• Device ID: K120282
• 510k Number: K120282
• Device Name: CARDNAV
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: PAIEON, INC. 23 HAMELACHA ST., P.O.B. 11355 Rosh Haayin, IL 48901
• Contact: Shimon Vaknin
• Correspondent: Shimon Vaknin; PAIEON, INC. 23 HAMELACHA ST., P.O.B. 11355 Rosh Haayin, IL 48901
• Product Code: OWB
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-31
• Decision Date: 2012-12-10
• Summary: summary