MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254— 510(k) K991458

Substantially Equivalent

Matsushita Electric Corp. of America

FDA 510(k) clearance K991458 for MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254, Substantially Equivalent on 2000-04-10. Applicant: Matsushita Electric Corp. of America.

Clearance details

Applicant: Matsushita Electric Corp. of America
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1999-04-26
Decision date: 2000-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.