WELCH ALLYN INSTRUMENT INTERFACE MODULE— 510(k) K001265

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K001265 for WELCH ALLYN INSTRUMENT INTERFACE MODULE, Substantially Equivalent on 2000-07-13. Applicant: Welch Allyn, Inc..

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2000-04-19
Decision date: 2000-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.