PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20— 510(k) K040479

Name: FDA 510(k) clearance K040479
Creator: U.S. Food and Drug Administration
Published: 2004-09-14

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K040479 for PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20, Substantially Equivalent on 2004-09-14. Applicant: Welch Allyn, Inc.. Device class: 3.

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code MKJ
Device class: Class 3
Regulation: 21 CFR 870.5310
Advisory panel: Cardiovascular
Date received: 2004-02-25
Decision date: 2004-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.