K172200 is an FDA 510(k) clearance for the 3880 MRI Patient Monitoring System. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).
Submitted by Iradimed Corporation (Winter Springs, US). The FDA issued a Cleared decision on October 25, 2017, 96 days after receiving the submission on July 21, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K172200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2017 |
| Decision Date | October 25, 2017 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |