The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Mri Compatible Patient Monitoring System, Model 3160.
| Device ID | K050399 |
| 510k Number | K050399 |
| Device Name: | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Neil Battiste |
| Correspondent | Neil Battiste INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-16 |
| Decision Date | 2005-08-26 |
| Summary: | summary |