510(k) K053462 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
3160 MRI PATIENT MONITORING SYSTEM
| Applicant | Invivo Corporation, Orlando FL, US |
| Decision | Substantially Equivalent, Jan 18, 2006 |
| Received | Dec 13, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053462
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2011 | Invivo Corporation Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits).
Label located on the back of the WPU. Product is labeled in part: "***In Terminated |
MWI | None listed |
| Feb 6, 2009 | Invivo Corporation 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826
These rechargeab Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.