510(k) K004017 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
H-SCRIBE
| Applicant | Mortara Instrument, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jun 11, 2001 |
| Received | Dec 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K004017
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring Open, Classified |
MLO | None listed |
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph Open, Classified |
MLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.