510(k) K092558 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES
| Applicant | Harvard Medical Devices , Ltd., Tsimshatsui, Kowloon, HK |
| Decision | Substantially Equivalent, Mar 17, 2010 |
| Received | Aug 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092558
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.