The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Velocity System V1.3.
| Device ID | K093942 |
| 510k Number | K093942 |
| Device Name: | ENSITE VELOCITY SYSTEM V1.3 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Donna Lunak |
| 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 | 2009-12-22 |
| Decision Date | 2010-02-25 |
| Summary: | summary |