510(k) K160718 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
| Applicant | Covidien, Boulder CO, US |
| Decision | Substantially Equivalent, Nov 14, 2016 |
| Received | Mar 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2026 | Covidien LLC HealthCast "Vital Sync" Remote Patient Monitoring System which consists of:
Product Number:
VSLBASE03P / VITALSYNCSW03
Model / UDI-DI codes:
Vital Sync 3.3.1 / 10884521844933
Vital Sync 3.4.0 / 108845 Open, Classified |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.