WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE— 510(k) K093907

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K093907 for WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE, Substantially Equivalent on 2010-04-14. Applicant: Welch Allyn, Inc..

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-12-22
Decision date: 2010-04-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

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.