The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto 3 Ep Navigation System, Version 2.0 (w/standard Location Pad),carto3 Epnavigation System,version 2.0 W/rmt Pad).
Device ID | K103746 |
510k Number | K103746 |
Device Name: | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) |
Classification | Computer, Diagnostic, Programmable |
Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
Contact | Wayne R Hohman |
Correspondent | Wayne R Hohman BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-23 |
Decision Date | 2011-01-21 |
Summary: | summary |