Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s— 510(k) K202892

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K202892 for Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s, Substantially Equivalent on 2021-01-28. Applicant: Edan Instruments, Inc..

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2020-09-28
Decision date: 2021-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.