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

Substantially Equivalent

Truly Instrument Co., Ltd.

FDA 510(k) clearance K091434 for TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M, Substantially Equivalent on 2009-09-04. Applicant: Truly Instrument Co., Ltd..

Clearance details

Applicant: Truly Instrument Co., Ltd.
Product code: Code DXN
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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Adverse events under product code DXN

product code DXN

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.