510(k) K133810 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
VC150 VITAL SIGNS MONITOR
| Applicant | Innokas Yhtyma, Kempele, Oulu, FI |
| Decision | Substantially Equivalent, Oct 30, 2014 |
| Received | Dec 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133810
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2016 | INNOKAS MEDICAL OY CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care. Terminated |
MWI | None listed |
| Nov 11, 2015 | Innokas Medical Oy CARESCAPE VC150 Vital Signs Monitor
Monitor vital signs in humans Terminated |
MWI | None listed |
| Jan 28, 2015 | INNOKAS MEDICAL OY VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, a Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.