The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto 3 Navigation System (model:fg-5400-00), Carto 3 External Reference Patches (model:d-1283-01).
| Device ID | K072202 |
| 510k Number | K072202 |
| Device Name: | CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Natalie Bennington |
| Correspondent | Natalie Bennington 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 | 2007-08-08 |
| Decision Date | 2007-11-19 |
| Summary: | summary |