TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11— 510(k) K081852

Substantially Equivalent

Truly Instrument Limited

FDA 510(k) clearance K081852 for TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11, Substantially Equivalent on 2008-12-12. Applicant: Truly Instrument Limited.

Clearance details

Applicant: Truly Instrument Limited
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2008-06-30
Decision date: 2008-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanwei City, Guangdong, 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.