The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Mri Patient Monitoring System (model 865214).
| Device ID | K124061 |
| 510k Number | K124061 |
| Device Name: | MRI PATIENT MONITORING SYSTEM (MODEL 865214) |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INVIVO CORPORATION 12151 RESEARCH PKWY Orlando, FL 32826 |
| Contact | Rusty Kelly |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-12-31 |
| Decision Date | 2013-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838033238 | K124061 | 000 |
| 00884838030411 | K124061 | 000 |