The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ep -nursemate, Ep -nursemate With Physio Module.
| Device ID | K093583 |
| 510k Number | K093583 |
| Device Name: | EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL 575 ROUTE 73 N BUILDING D West Berlin, NJ 08901 |
| Contact | Tim Kappers |
| 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 | 2009-11-19 |
| Decision Date | 2009-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734207782 | K093583 | 000 |