The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Velocity System V.3.0.
| Device ID | K112688 |
| 510k Number | K112688 |
| Device Name: | ENSITE VELOCITY SYSTEM V.3.0 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Donna R Lunak |
| Correspondent | Donna R Lunak ST. JUDE MEDICAL One St. Jude Medical Drive St. Paul, MN 55117 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-15 |
| Decision Date | 2011-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067001863 | K112688 | 000 |
| 05415067001856 | K112688 | 000 |
| 05415067000910 | K112688 | 000 |
| 05414734219211 | K112688 | 000 |
| 05414734219228 | K112688 | 000 |