510(k) K090785 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
| Applicant | Invivo Corp., Orlando FL, US |
| Decision | Substantially Equivalent, Dec 15, 2009 |
| Received | Mar 23, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090785
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2020 | Philips North America, LLC Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor Terminated |
MWI | None listed |
| Jun 18, 2020 | Philips North America, LLC Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs Terminated |
MWI | None listed |
| Jun 18, 2020 | Philips North America, LLC Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for Terminated |
MWI | None listed |
| Apr 13, 2020 | Philips North America, LLC Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respi Terminated |
MWI | None listed |
| Dec 4, 2012 | Invivo Corporation Invivo Corporation Expression MRI Patient Monitoring System.
The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoin Terminated |
MWI | None listed |
| Oct 25, 2011 | Invivo Corporation "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564 Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.