The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Philips Mr Patient Care Portal.
| Device ID | K212227 |
| 510k Number | K212227 |
| Device Name: | Philips MR Patient Care Portal |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Invivo Corporation 12151 Research Parkway Orlando, FL 32826 |
| Contact | Maria Keelan |
| Correspondent | Maria Keelan Invivo Corporation 12151 Research Parkway Orlando, FL 32826 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-16 |
| Decision Date | 2021-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838091948 | K212227 | 000 |