REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351— 510(k) K052465

Substantially Equivalent

Heartsine Technologies, Inc.

FDA 510(k) clearance K052465 for REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351, Substantially Equivalent on 2006-12-12. Applicant: Heartsine Technologies, Inc..

Clearance details

Applicant: Heartsine Technologies, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2005-09-08
Decision date: 2006-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, PA, US

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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.