The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Avivo Mobile Patient Management (mpm) System.
| Device ID | K153160 |
| 510k Number | K153160 |
| Device Name: | AVIVO Mobile Patient Management (MPM) System |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | MEDTRONIC, INC. 8200 CORAL SEA STREET NE Mounds View, MN 55112 |
| Contact | Cheryl L. Swanson |
| Correspondent | Cheryl L. Swanson MEDTRONIC, INC. 8200 CORAL SEA STREET NE Mounds View, MN 55112 |
| Product Code | MHX |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-02 |
| Decision Date | 2016-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169651180 | K153160 | 000 |
| 00763000065720 | K153160 | 000 |
| 00763000065713 | K153160 | 000 |
| 00763000065706 | K153160 | 000 |