510(k) K120536— HEART SYNC PEDIATRIC PHYSIO AED PAD

Substantially Equivalent

Heart Sync, Inc.

Clearance details

Applicant: Heart Sync, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2012-02-22
Decision date: 2012-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, 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.