510(k) K152770 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
ProBP 2400 Digital Blood Pressure Device
| Applicant | Microlife Intellectual Property GmbH, Widnau, CH |
| Decision | Substantially Equivalent, Oct 21, 2015 |
| Received | Sep 25, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152770
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2017 | Welch Allyn Inc Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Co Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.