The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto Xp Ep Navigation System, Software Verison 8.
| Device ID | K042999 |
| 510k Number | K042999 |
| Device Name: | CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Mark O'donnell |
| Correspondent | Mark O'donnell BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-03-21 |
| Summary: | summary |