The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ep-workmate System, Version 4.2.
| Device ID | K092810 |
| 510k Number | K092810 |
| Device Name: | EP-WORKMATE SYSTEM, VERSION 4.2 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL 575 ROUTE 73 N BUILDING D West Berlin, NJ 08901 |
| Contact | Timothy J Kappers |
| Correspondent | Timothy J Kappers ST. JUDE MEDICAL 575 ROUTE 73 N BUILDING D West Berlin, NJ 08901 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-11 |
| Decision Date | 2009-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067003560 | K092810 | 000 |
| 05414734219105 | K092810 | 000 |
| 05415067000866 | K092810 | 000 |
| 05415067000965 | K092810 | 000 |
| 05415067000972 | K092810 | 000 |
| 05415067003119 | K092810 | 000 |
| 05415067003126 | K092810 | 000 |
| 05415067003461 | K092810 | 000 |
| 05415067003553 | K092810 | 000 |
| 05414734207546 | K092810 | 000 |