510(k) K142244 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
CLEO PATIENT MONITOR
| Applicant | Infinium Medical, Largo FL, US |
| Decision | Substantially Equivalent, Feb 6, 2015 |
| Received | Aug 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142244
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2019 | Infinium Medical, Inc CLEO Patient Monitor /Tranquility VS Patient Monitor Open, Classified |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.