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: K200313
• 510k Number: K200313
• Device Name: VIVO
• Classification: Computer, Diagnostic, Programmable
• Applicant: Catheter Precision, Inc. 500 International Drive, Suite 255 Mt. Olive, NJ 07828
• Contact: Steve Adler
• Correspondent: Steve Adler; Catheter Precision, Inc. 500 International Drive, Suite 255 Mt. Olive, NJ 07828
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-02-06
• Decision Date: 2020-09-14