The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Mediguide Technology System.
| Device ID | K162643 |
| 510k Number | K162643 |
| Device Name: | MediGuide Technology System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ST. JUDE MEDICAL ONE ST. JUDE MEDICAL DRIVE St. Paul, MN 55117 |
| Contact | Marlene Peterson |
| Correspondent | Marlene Peterson 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-22 |
| Decision Date | 2016-12-13 |
| Summary: | summary |