WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES— 510(k) K041693

Clearance details

Applicant

Hangzhou Hua'An Medical & Health Instruments Co.,

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

2004-06-22

Decision date

2004-12-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hangzhou, Zhejiang, CN

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• K122912 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)2012-11-07
• K092447 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES2010-01-07
• K092514 — UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES2009-12-04
• K041692 — INFRARED EAR THERMOMETER, ET-100 SERIES2004-09-13
• K041694 — DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER2004-09-13

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 →