BLOOD PRESSURE MONITOR— 510(k) K812936

Substantially Equivalent

Amertek

FDA 510(k) clearance K812936 for BLOOD PRESSURE MONITOR, Substantially Equivalent on 1981-12-14. Applicant: Amertek.

Clearance details

Applicant: Amertek
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1981-10-20
Decision date: 1981-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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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.