CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION— 510(k) K023286

Substantially Equivalent

Neptec Design Group, Ltd.

FDA 510(k) clearance K023286 for CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION, Substantially Equivalent on 2003-05-02. Applicant: Neptec Design Group, Ltd..

Clearance details

Applicant: Neptec Design Group, Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2002-10-02
Decision date: 2003-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanata, Ontario, CA

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.