510(k) K122073 ยท DPS Electrocardiograph
ELI 280 ELECTROCARDIOGRAPH
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 2, 2012 |
| Received | Jul 16, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122073
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2021 | Welch Allyn Inc Mortara ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers:
ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX,
ELI280-BCB- Open, Classified |
DPS | None listed |
| Mar 31, 2021 | Welch Allyn Inc Mortara ELI 280 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.