WELCH ALLYN ABPM 6100— 510(k) K021756

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K021756 for WELCH ALLYN ABPM 6100, Substantially Equivalent on 2002-06-27. Applicant: Welch Allyn, Inc..

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2002-05-29
Decision date: 2002-06-27
Decision: Substantially Equivalent
Clearance type: Special
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.