The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Expression Mr400 Mri Patient Monitoring System.
| Device ID | K152330 |
| 510k Number | K152330 |
| Device Name: | Expression MR400 MRI Patient Monitoring System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | INVIVO CORPORATION 12151 RESEARCH PARKWAY, SUITE 200 Orlando, FL 32826 |
| Contact | Rusty Kelly |
| Correspondent | Christine Trefethen PHILIPS MEDICAL SYSTEMS 3000 Minuteman Rd Andover, MA 01801 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-18 |
| Decision Date | 2015-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838056794 | K152330 | 000 |
| 00884838039131 | K152330 | 000 |
| 00884838054899 | K152330 | 000 |
| 00884838054905 | K152330 | 000 |
| 00884838054912 | K152330 | 000 |
| 00884838054929 | K152330 | 000 |
| 00884838054936 | K152330 | 000 |
| 00884838054943 | K152330 | 000 |
| 00884838055001 | K152330 | 000 |
| 00884838055018 | K152330 | 000 |
| 00884838055025 | K152330 | 000 |
| 00884838055032 | K152330 | 000 |
| 00884838055285 | K152330 | 000 |
| 00884838056077 | K152330 | 000 |
| 00884838056312 | K152330 | 000 |