510(k) K012054 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
| Applicant | Sein Electronics Co., Ltd., Anyang-City, Kyunggi-Do, KR |
| Decision | Substantially Equivalent, Aug 8, 2001 |
| Received | Jul 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012054
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.