The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Medtronic Temporary External Pacemaker 53401.
| Device ID | K162054 |
| 510k Number | K162054 |
| Device Name: | Medtronic Temporary External Pacemaker 53401 |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | MEDTRONIC, INC. 8200 CORAL SEA STREET NE Mounds View, MN 55112 |
| Contact | Syed Sumran Mohiuddin |
| Correspondent | Syed Sumran Mohiuddin MEDTRONIC, INC. 8200 CORAL SEA STREET NE Mounds View, MN 55112 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-25 |
| Decision Date | 2016-10-18 |
| Summary: | summary |