HEART SYNC, MODELS C-100 AND T-100— 510(k) K080421

Substantially Equivalent

Heart Sync, LLC

FDA 510(k) clearance K080421 for HEART SYNC, MODELS C-100 AND T-100, Substantially Equivalent on 2008-02-29. Applicant: Heart Sync, LLC.

Clearance details

Applicant: Heart Sync, LLC
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2008-02-15
Decision date: 2008-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, 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.