The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Essential Mri Patient Monitor.
| Device ID | K103700 |
| 510k Number | K103700 |
| Device Name: | ESSENTIAL MRI PATIENT MONITOR |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-20 |
| Decision Date | 2011-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838046801 | K103700 | 000 |
| 00884838012585 | K103700 | 000 |