AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)— 510(k) K030230

Substantially Equivalent

Avita Corporation

FDA 510(k) clearance K030230 for AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR), Substantially Equivalent on 2003-05-23. Applicant: Avita Corporation.

Clearance details

Applicant: Avita Corporation
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2003-01-22
Decision date: 2003-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, 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.