K240794
- 510(k) number
- K240794
- Device name
- Frontier X Plus
- Applicant
- Fourth Frontier Technologies Pvt, Ltd. IN
- Product code
- MLO — Electrocardiograph, Ambulatory, With Analysis Algori
- Decision date
- 2024-11-08
- Date received
- 2024-03-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240794.pdf
Official FDA record: K240794
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.