AMC Health CareConsole— 510(k) K233446

Substantially Equivalent

Amc Health

FDA 510(k) clearance K233446 for AMC Health CareConsole, Substantially Equivalent on 2024-09-27. Applicant: Amc Health.

Clearance details

Applicant: Amc Health
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2023-10-19
Decision date: 2024-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.