BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019— 510(k) K091897

Substantially Equivalent

Taidoc Technology Corporation

FDA 510(k) clearance K091897 for BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019, Substantially Equivalent on 2009-08-25. Applicant: Taidoc Technology Corporation.

Clearance details

Applicant: Taidoc Technology Corporation
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-06-24
Decision date: 2009-08-25
Decision: Substantially Equivalent
Clearance type: Special
Location: New Taipei City, TW

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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.