VITAL SIGNS MONITOR— 510(k) K153135

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

2015-10-30

Decision date

2016-02-25

Decision

Substantially Equivalent

Clearance type

Special

Location

Zhuhai,, CN

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• K181919 — Patient Monitor2019-04-05
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• K160349 — Electronic Sphygmomanometer2016-11-03
• K153580 — Central Monitoring System2016-09-07

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 →