MAPMATE

Computer, Diagnostic, Programmable

EP MEDSYSTEMS, INC.

The following data is part of a premarket notification filed by Ep Medsystems, Inc. with the FDA for Mapmate.

Pre-market Notification Details

• Device ID: K063277
• 510k Number: K063277
• Device Name: MAPMATE
• Classification: Computer, Diagnostic, Programmable
• Applicant: EP MEDSYSTEMS, INC. COOPER RUN EXECUTIVE PARK 575 ROUTE 73 NORTH, BUILDING D West Berlin, NJ 08091 -9293
• Contact: Larry Picciano
• Correspondent: Larry Picciano; EP MEDSYSTEMS, INC. COOPER RUN EXECUTIVE PARK 575 ROUTE 73 NORTH, BUILDING D West Berlin, NJ 08091 -9293
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-10-31
• Decision Date: 2006-11-30
• Summary: summary