The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ep-workmate, Ep-nursemate, Ep-nursemate With Physio Module.
| Device ID | K132073 |
| 510k Number | K132073 |
| Device Name: | EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL One St. Jude Medical Drive St. Paul, MN 55117 |
| Contact | Kris Miller |
| Correspondent | Kris Miller 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 | 2013-07-03 |
| Decision Date | 2013-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067018090 | K132073 | 000 |
| 05415067001306 | K132073 | 000 |
| 05415067001290 | K132073 | 000 |
| 05415067001283 | K132073 | 000 |
| 05415067001252 | K132073 | 000 |
| 05415067001245 | K132073 | 000 |
| 05415067001238 | K132073 | 000 |
| 05415067001214 | K132073 | 000 |
| 05415067001207 | K132073 | 000 |
| 05415067001191 | K132073 | 000 |
| 05415067001184 | K132073 | 000 |
| 05415067001160 | K132073 | 000 |
| 05415067000897 | K132073 | 000 |
| 05415067000880 | K132073 | 000 |
| 05415067017031 | K132073 | 000 |
| 05415067001313 | K132073 | 000 |
| 05415067001337 | K132073 | 000 |
| 05415067010605 | K132073 | 000 |
| 05415067009777 | K132073 | 000 |
| 05415067001634 | K132073 | 000 |
| 05415067001610 | K132073 | 000 |
| 05415067001597 | K132073 | 000 |
| 05415067001580 | K132073 | 000 |
| 05415067001573 | K132073 | 000 |
| 05415067001566 | K132073 | 000 |
| 05415067001542 | K132073 | 000 |
| 05415067001535 | K132073 | 000 |
| 05415067001528 | K132073 | 000 |
| 05415067001511 | K132073 | 000 |
| 05415067001504 | K132073 | 000 |
| 05415067001382 | K132073 | 000 |
| 05415067001559 | K132073 | 000 |