510(k) K023338 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2
| Applicant | Fms, Finapres Medical Systems BV, Santa Barbara CA, US |
| Decision | Substantially Equivalent, May 9, 2003 |
| Received | Oct 7, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2012 | FMS, Finapres Medical Systems BV Finapres Medical Systems Portapres with NiMh battery pack
Product Usage:
Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be us Terminated |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.