The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Velocity Cardiac Mapping System V5.0, Ensite Automap Module V1.0.
| Device ID | K160187 |
| 510k Number | K160187 |
| Device Name: | Ensite Velocity Cardiac Mapping System V5.0, Ensite Automap Module V1.0 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL ONE ST. JUDE MEDICAL St. Paul, MN 55117 |
| Contact | Melissa Frank |
| Correspondent | Melissa Frank ST. JUDE MEDICAL ONE ST. JUDE MEDICAL St. Paul, MN 55117 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067027733 | K160187 | 000 |
| 05415067026132 | K160187 | 000 |
| 05415067026170 | K160187 | 000 |
| 05415067026187 | K160187 | 000 |
| 05415067026194 | K160187 | 000 |
| 05415067026200 | K160187 | 000 |
| 05415067026217 | K160187 | 000 |
| 05415067026224 | K160187 | 000 |
| 05415067026293 | K160187 | 000 |
| 05415067026101 | K160187 | 000 |