510(k) K142105 ยท DPS Electrocardiograph
ELI 380 ELECTROCARDIOGRAPH
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Sep 5, 2014 |
| Received | Aug 1, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142105
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2023 | Baxter Healthcare Corporation Baxter Electrocardiograph, ELI 380 -DCS21 Terminated |
DPS | None listed |
| Mar 31, 2021 | Welch Allyn Inc Mortara ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. Terminated |
DPS | None listed |
| Jun 12, 2015 | Mortara Instrument, Inc ELI 380 Electrocardiograph.
The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380
simultaneously acquires data from ea Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.