The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Expression Information Portal.
| Device ID | K121424 |
| 510k Number | K121424 |
| Device Name: | EXPRESSION 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 | 2012-05-14 |
| Decision Date | 2012-06-13 |
| Summary: | summary |