PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037— 510(k) K042818

Substantially Equivalent

Matsushita Electric Works, Ltd.

FDA 510(k) clearance K042818 for PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037, Substantially Equivalent on 2005-01-27. Applicant: Matsushita Electric Works, Ltd..

Clearance details

Applicant: Matsushita Electric Works, Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2004-10-12
Decision date: 2005-01-27
Decision: Substantially Equivalent
Clearance type: Special
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.