PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP— 510(k) K860634

Substantially Equivalent

Panasonic Co. Div. Matsu Elec. Corp. America

FDA 510(k) clearance K860634 for PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP, Substantially Equivalent on 1986-07-01. Applicant: Panasonic Co. Div. Matsu Elec. Corp. America.

Clearance details

Applicant: Panasonic Co. Div. Matsu Elec. Corp. America
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1986-02-20
Decision date: 1986-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Secaucus, NJ, 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.