510(k) K171751 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module
| Applicant | Capsule Technologie Sas, Andover MA, US |
| Decision | Substantially Equivalent, Oct 24, 2017 |
| Received | Jun 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171751
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.