The following data is part of a premarket notification filed by Medtronic, Inc with the FDA for Patient Assistant Model Pa97000.
| Device ID | K190574 |
| 510k Number | K190574 |
| Device Name: | Patient Assistant Model PA97000 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | Medtronic, Inc 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Cheryl Swanson |
| Correspondent | Cheryl Swanson 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 | 2019-03-06 |
| Decision Date | 2019-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000180904 | K190574 | 000 |