The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto Rmt Ep Navigation System V8.
| Device ID | K060047 |
| 510k Number | K060047 |
| Device Name: | CARTO RMT EP NAVIGATION SYSTEM V8 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Diana Thorson |
| Correspondent | Diana Thorson BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-06 |
| Decision Date | 2006-06-19 |
| Summary: | summary |