CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM— 510(k) K063547

Substantially Equivalent

Witt Biomedical Corp

FDA 510(k) clearance K063547 for CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM, Substantially Equivalent on 2006-12-21. Applicant: Witt Biomedical Corp.

Clearance details

Applicant: Witt Biomedical Corp
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2006-11-24
Decision date: 2006-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Melbourne, FL, US

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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.