K172510 is an FDA 510(k) clearance for the µCor Heart Failure and Arrhythmia Management System. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Zoll Manufacturing Corporation (Pittsburgh, US). The FDA issued a Cleared decision on May 11, 2018, 263 days after receiving the submission on August 21, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K172510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2017 |
| Decision Date | May 11, 2018 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| 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 |