The following data is part of a premarket notification filed by Invivo Corporation with the FDA for 3160 Mri Patient Monitoring System.
| Device ID | K053462 |
| 510k Number | K053462 |
| Device Name: | 3160 MRI PATIENT MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INVIVO CORPORATION 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Neil Battiste |
| Correspondent | Neil Battiste INVIVO CORPORATION 12601 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 | 2005-12-13 |
| Decision Date | 2006-01-18 |
| Summary: | summary |