510(k) K161909 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
IQvitals Zone
| Applicant | Midmark Corporation, Torrance CA, US |
| Decision | Substantially Equivalent, Nov 17, 2016 |
| Received | Jul 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161909
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Midmark Corporation Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients Open, Classified |
MWI | None listed |
| Sep 18, 2026 | Midmark Corporation Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients Open, Classified |
MWI | None listed |
| Sep 18, 2026 | Midmark Corporation Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients Open, Classified |
MWI | None listed |
| Sep 18, 2026 | Midmark Corporation Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients Open, Classified |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.