Truscope Ultra Patient Monitor— 510(k) K162234

Name: FDA 510(k) clearance K162234
Creator: U.S. Food and Drug Administration
Published: 2017-01-04

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.. Device class: 2.

Clearance details

Applicant: Guangdong Biolight Meditech Co., Ltd.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
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 ↗

Recent devices under product code MWI

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K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

More clearances from Guangdong Biolight Meditech Co., Ltd.

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K181919 — Patient Monitor2019-04-05
K170514 — Central Monitoring System2017-05-24
K160349 — Electronic Sphygmomanometer2016-11-03
K153580 — Central Monitoring System2016-09-07
K153135 — VITAL SIGNS MONITOR2016-02-25

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.