K233038

Substantially Equivalent

Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s

Applicant: Edan Instruments, Inc.
Product code: MWI
Advisory panel: Cardiovascular
Date received: 2023-09-25
Decision date: 2024-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.