510(k) K152006 ยท DXQ Blood Pressure Cuff
Cogent Hemodynamic Monitoring System
| Applicant | Icu Medical, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, May 5, 2016 |
| Received | Jul 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2020 | ICU Medical, Inc. icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diag Terminated |
DXG | None listed |
| Feb 14, 2020 | ICU Medical, Inc. The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intende Terminated |
DXG | None listed |
| Jul 12, 2019 | ICU Medical, Inc. ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499 Terminated |
DXQ | None listed |
| Jan 5, 2018 | ICU Medical, Inc. Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000).
Intended for patients for whom the monitoring Terminated |
DXQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.