510(k) K081159 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES
| Applicant | Harvard Medical Devices , Ltd., Tsimshatsui, Kowloon, HK |
| Decision | Substantially Equivalent, Aug 8, 2008 |
| Received | Apr 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081159
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.