The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Noga Xp Cardiac Navigation System With Qwikmap Software.
| Device ID | K053194 |
| 510k Number | K053194 |
| Device Name: | NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | BIOSENSE WEBSTER, INC. 2400 VIA CARRILLO Palos Verdes Estates, CA 90274 |
| Contact | Sigi Caron |
| Correspondent | Sigi Caron BIOSENSE WEBSTER, INC. 2400 VIA CARRILLO Palos Verdes Estates, CA 90274 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-15 |
| Decision Date | 2006-03-09 |
| Summary: | summary |