510(k) K152944 ยท DPS Electrocardiograph
Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jan 6, 2016 |
| Received | Oct 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152944
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test Open, Classified |
DPS | None listed |
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer Open, Classified |
DPS | None listed |
| Jan 10, 2024 | Baxter Healthcare Corporation Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes:
a) QS6 AM12Q KIT AHA XML / QS6-BXXCS:
b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX:
c) QS6 AM12Q KIT Z200 BCRT Open, Classified |
DPS | None listed |
| Jan 10, 2024 | Baxter Healthcare Corporation XScribe Cardiac Stress Testing System, version 6, with below product names and codes:
a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX;
b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX;
c) XS6/RS6 REVIEW WKSTN KI Open, Classified |
DPS | None listed |
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquis Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.