PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602— 510(k) K002280

Substantially Equivalent

Medical Devices, Inc.

FDA 510(k) clearance K002280 for PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602, Substantially Equivalent on 2001-02-05. Applicant: Medical Devices, Inc..

Clearance details

Applicant: Medical Devices, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2000-07-26
Decision date: 2001-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Moines, IA, US

Download summary PDF View on FDA.gov ↗

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.