The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Medtronic Patient Asistant.
| Device ID | K150117 |
| 510k Number | K150117 |
| Device Name: | Medtronic Patient Asistant |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Eric Kalmes |
| Correspondent | Eric Kalmes Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169571129 | K150117 | 000 |
| 00643169476998 | K150117 | 000 |