DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900— 510(k) K052784

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K052784 for DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900, Substantially Equivalent on 2005-11-22. Applicant: Welch Allyn, Inc..

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2005-10-03
Decision date: 2005-11-22
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.