FDA 510(k), K191660, CARTO 3 EP Navigation System, Version 7.1 and Accessories

510(K) Number: K191660
Device Name: CARTO 3 EP Navigation System, Version 7.1 and Accessories
Manufacturer: Phuong Chau
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: 06/21/2019
Date Received: 07/20/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular

428 pages (72 of 500 original pages are fully redacted)