RT Carbon ECG Leads— 510(k) K240087

Substantially Equivalent

Ivy Biomedical Systems, Inc.

FDA 510(k) clearance K240087 for RT Carbon ECG Leads, Substantially Equivalent on 2024-09-13. Applicant: Ivy Biomedical Systems, Inc..

Clearance details

Applicant: Ivy Biomedical Systems, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2024-01-11
Decision date: 2024-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.