TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M— 510(k) K091434

Clearance details

Applicant

Truly Instrument Co., Ltd.

Product code

Code DXN

Device class

Class 2

Regulation

21 CFR 870.1130

Advisory panel

Cardiovascular

Date received

2009-05-13

Decision date

2009-09-04

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Shanwei Shi, Guang Dong, CN

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• K113083 — TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR2012-01-19
• K113085 — TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR2012-01-12
• K091415 — TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M2009-09-04

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 →