510(k) K100127 ยท DPS Electrocardiograph
ELI 230 ELECTROCARDIOGRAPH
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Apr 16, 2010 |
| Received | Jan 19, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K100127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2020 | WELCH ALLYN, INC/MORTARA Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio.
Product Usage: A non-invasive prescr Terminated |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.