MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR— 510(k) K131346

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

2013-05-09

Decision date

2013-06-06

Decision

Substantially Equivalent

Clearance type

Special

Location

Great Neck, NY, US

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• K211776 — Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)2022-03-01
• K211288 — Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B2021-11-04

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 →