PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA— 510(k) K051565

Substantially Equivalent

Proton Healthcare , Ltd.

FDA 510(k) clearance K051565 for PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA, Substantially Equivalent on 2005-09-12. Applicant: Proton Healthcare , Ltd..

Clearance details

Applicant: Proton Healthcare , Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2005-06-14
Decision date: 2005-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, 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.