The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Mri Patient Monitoring System.
| Device ID | K132359 |
| 510k Number | K132359 |
| Device Name: | MRI PATIENT MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INVIVO CORPORATION 12151 RESEARCH PKWY Orlando, FL 32826 |
| Contact | Rusty Kelly |
| Correspondent | Rusty Kelly INVIVO CORPORATION 12151 RESEARCH PKWY Orlando, FL 32826 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-30 |
| Decision Date | 2013-08-30 |
| Summary: | summary |