Handheld VitalSigns Monitoring System— 510(k) K172965

Substantially Equivalent

Visiomed Technology Co.,Ltd

FDA 510(k) clearance K172965 for Handheld VitalSigns Monitoring System, Substantially Equivalent on 2018-12-17. Applicant: Visiomed Technology Co.,Ltd.

Clearance details

Applicant: Visiomed Technology Co.,Ltd
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2017-09-26
Decision date: 2018-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bao An, 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.