XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION— 510(k) K063840

Substantially Equivalent

Witt Biomedical Corp

FDA 510(k) clearance K063840 for XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION, Substantially Equivalent on 2007-02-06. Applicant: Witt Biomedical Corp.

Clearance details

Applicant: Witt Biomedical Corp
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2006-12-26
Decision date: 2007-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.