NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT— 510(k) K082599

Substantially Equivalent

Cnsystem Medizintechnik AG

FDA 510(k) clearance K082599 for NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT, Substantially Equivalent on 2008-10-17. Applicant: Cnsystem Medizintechnik AG.

Clearance details

Applicant: Cnsystem Medizintechnik AG
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2008-09-08
Decision date: 2008-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Graz, AT

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.