510(k) K212227 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Philips MR Patient Care Portal
| Applicant | Invivo Corporation, Orlando FL, US |
| Decision | Substantially Equivalent, Sep 30, 2021 |
| Received | Jul 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212227
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2022 | Philips North America Llc MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561
This is a component of product number 866162. Open, Classified |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.