K053462 is an FDA 510(k) clearance for the 3160 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 Invivo Corporation (Orlando, US). The FDA issued a Cleared decision on January 18, 2006, 36 days after receiving the submission on December 13, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K053462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2005 |
| Decision Date | January 18, 2006 |
| Days to Decision | 36 days |
| Submission Type | Special |
| 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 |