WRISTWATCH BLOOD PRESSURE MONITOR A46— 510(k) K010498

Substantially Equivalent

Rossmax Internationl , Ltd.

FDA 510(k) clearance K010498 for WRISTWATCH BLOOD PRESSURE MONITOR A46, Substantially Equivalent on 2001-03-20. Applicant: Rossmax Internationl , Ltd..

Clearance details

Applicant: Rossmax Internationl , Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-02-21
Decision date: 2001-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Taipei, 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.