XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS— 510(k) K101571

Substantially Equivalent

Witt Biomedical Corp

FDA 510(k) clearance K101571 for XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS, Substantially Equivalent on 2010-10-26. Applicant: Witt Biomedical Corp.

Clearance details

Applicant: Witt Biomedical Corp
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2010-06-04
Decision date: 2010-10-26
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.