The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Medtronic Model 5392 External Pulse Generator (epg).
| Device ID | K190825 |
| 510k Number | K190825 |
| Device Name: | Medtronic Model 5392 External Pulse Generator (EPG) |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Alexandra Theisen |
| Correspondent | Alexandra Theisen Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-04-30 |