SPHYGMOCOR PX MODEL SCOR-PX— 510(k) K012487

Substantially Equivalent

Atcor Medical Pty, Ltd.

FDA 510(k) clearance K012487 for SPHYGMOCOR PX MODEL SCOR-PX, Substantially Equivalent on 2002-02-21. Applicant: Atcor Medical Pty, Ltd..

Clearance details

Applicant: Atcor Medical Pty, Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-08-02
Decision date: 2002-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

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.