K052465

Substantially Equivalent

REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351

Applicant: Heartsine Technologies, Inc.
Product 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

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.