HEART SYNC PEDIATRIC, MODEL PED-100— 510(k) K081442

Substantially Equivalent

Heart Sync, LLC

FDA 510(k) clearance K081442 for HEART SYNC PEDIATRIC, MODEL PED-100, Substantially Equivalent on 2008-09-24. Applicant: Heart Sync, LLC.

Clearance details

Applicant: Heart Sync, LLC
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 2008-05-22
Decision date: 2008-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.