WINNER SELF-TAKING HOME BLOOD PRESSURE KIT— 510(k) K942163

Substantially Equivalent

Winmed Instruments Mfg. Corp.

FDA 510(k) clearance K942163 for WINNER SELF-TAKING HOME BLOOD PRESSURE KIT, Substantially Equivalent on 1994-12-20. Applicant: Winmed Instruments Mfg. Corp..

Clearance details

Applicant: Winmed Instruments Mfg. Corp.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1994-05-04
Decision date: 1994-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei 11599, TW

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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.