K153160 is an FDA 510(k) clearance for the AVIVO Mobile Patient Management (MPM) System. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on March 30, 2016, 149 days after receiving the submission on November 2, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K153160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2015 |
| Decision Date | March 30, 2016 |
| Days to Decision | 149 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |