The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Expression Mr200 Mri Patient Monitoring System, Expression Ip5 Information Portal.
| Device ID | K131382 |
| 510k Number | K131382 |
| Device Name: | EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL |
| 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 | 2013-05-14 |
| Decision Date | 2013-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838044678 | K131382 | 000 |
| 00884838034044 | K131382 | 000 |
| 00884838034037 | K131382 | 000 |
| 00884838034020 | K131382 | 000 |
| 00884838034013 | K131382 | 000 |
| 00884838034006 | K131382 | 000 |
| 00884838033993 | K131382 | 000 |
| 00884838033986 | K131382 | 000 |
| 00884838033764 | K131382 | 000 |
| 00884838031890 | K131382 | 000 |
| 00884838029729 | K131382 | 000 |
| 20884838037834 | K131382 | 000 |
| 20884838037827 | K131382 | 000 |
| 20884838037810 | K131382 | 000 |
| 20884838037803 | K131382 | 000 |
| 20884838037797 | K131382 | 000 |
| 20884838037780 | K131382 | 000 |
| 00884838034051 | K131382 | 000 |
| 00884838034068 | K131382 | 000 |
| 00884838044661 | K131382 | 000 |
| 00884838044449 | K131382 | 000 |
| 00884838039094 | K131382 | 000 |
| 00884838035072 | K131382 | 000 |
| 00884838035065 | K131382 | 000 |
| 00884838035058 | K131382 | 000 |
| 00884838035041 | K131382 | 000 |
| 00884838035034 | K131382 | 000 |
| 00884838034143 | K131382 | 000 |
| 00884838034136 | K131382 | 000 |
| 00884838034129 | K131382 | 000 |
| 00884838034112 | K131382 | 000 |
| 00884838034105 | K131382 | 000 |
| 00884838034099 | K131382 | 000 |
| 00884838034082 | K131382 | 000 |
| 00884838034075 | K131382 | 000 |
| 10884838037837 | K131382 | 000 |