WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES— 510(k) K101680

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K101680 for WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES, Substantially Equivalent on 2010-07-09. Applicant: Welch Allyn, Inc..

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2010-06-15
Decision date: 2010-07-09
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.