K240087
- 510(k) number
- K240087
- Device name
- RT Carbon ECG Leads
- Applicant
- Ivy Biomedical Systems, Inc. CT · US
- Product code
- DSA — Cable, Transducer And Electrode, Patient, (Including
- Decision date
- 2024-09-13
- Date received
- 2024-01-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K240087.pdf
Official FDA record: K240087
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.