VIVO

Computer, Diagnostic, Programmable

Catheter Precision, Inc.

The following data is part of a premarket notification filed by Catheter Precision, Inc. with the FDA for Vivo.

Pre-market Notification Details

• Device ID: K183195
• 510k Number: K183195
• Device Name: VIVO
• Classification: Computer, Diagnostic, Programmable
• Applicant: Catheter Precision, Inc. 1705 Route 46 Ledgewood, NJ 07852
• Contact: Steve Adler
• Correspondent: Karen Bannick; Catheter Precision, Inc. 1705 Route 46 Ledgewood, NJ 07852
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-19
• Decision Date: 2019-06-14