Truscope Ultra Patient Monitor— 510(k) K162234

Substantially Equivalent

Guangdong Biolight Meditech Co., Ltd.

FDA 510(k) clearance K162234 for Truscope Ultra Patient Monitor, Substantially Equivalent on 2017-01-04. Applicant: Guangdong Biolight Meditech Co., Ltd..

Clearance details

Applicant: Guangdong Biolight Meditech Co., Ltd.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2016-08-09
Decision date: 2017-01-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Zhuhai,, 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.