The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Fusion Dynamic Registration Tool.
| Device ID | K082467 |
| 510k Number | K082467 |
| Device Name: | ENSITE FUSION DYNAMIC REGISTRATION TOOL |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL 1350 ENERGY LN., SUITE 110 St. Paul, MN 55108 |
| Contact | Karen J Mckelvey |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-27 |
| Decision Date | 2008-09-11 |