Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)— 510(k) K222153

Clearance details

Applicant

Microlife Intellectual Property GmbH

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

2022-07-20

Decision date

2023-02-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Widnau, CH

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• K202729 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor2021-04-08

Death

3

Injury

169

Malfunction

1,019

Other

2

Total

1,193

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 →