MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1— 510(k) K013485

Substantially Equivalent

Microlife Corp.

FDA 510(k) clearance K013485 for MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1, Substantially Equivalent on 2002-01-17. Applicant: Microlife Corp..

Clearance details

Applicant: Microlife Corp.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-10-19
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, 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.