The following data is part of a premarket notification filed by Fms, Finapres Medical Systems Bv with the FDA for Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,model-2.
| Device ID | K023338 |
| 510k Number | K023338 |
| Device Name: | PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | FMS, FINAPRES MEDICAL SYSTEMS BV 1205 DE LA VINA ST. Santa Barbara, CA 93101 |
| Contact | Christine Emanuel |
| Correspondent | Christine Emanuel FMS, FINAPRES MEDICAL SYSTEMS BV 1205 DE LA VINA ST. Santa Barbara, CA 93101 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-07 |
| Decision Date | 2003-05-09 |
| Summary: | summary |