510(k) K120865 ยท DPS Electrocardiograph
RSCRIBE ELECTROCARDIOGRAPH
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jul 19, 2012 |
| Received | Mar 22, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120865
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph Open, Classified |
DPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.