510(k) K101680 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
| Applicant | Welch Allyn, Inc., Skaneateles Falls NY, US |
| Decision | Substantially Equivalent, Jul 9, 2010 |
| Received | Jun 15, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101680
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models:
a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2;
b) PROBP 3400, SUREBP, Open, Classified |
DXN | None listed |
| Apr 22, 2021 | Welch Allyn Inc ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models)
Model: 34XFHT-B
Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonate Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.