AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100— 510(k) K043550

Substantially Equivalent

Amplife Corporation

FDA 510(k) clearance K043550 for AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100, Substantially Equivalent on 2005-01-27. Applicant: Amplife Corporation.

Clearance details

Applicant: Amplife Corporation
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2004-12-23
Decision date: 2005-01-27
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.