K243837
- 510(k) number
- K243837
- Device name
- iBSM
- Applicant
- Iorbit Digital Technologies Private Limited IN
- Product code
- DRG — Transmitters And Receivers, Physiological Signal, Ra
- Decision date
- 2025-05-16
- Date received
- 2024-12-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243837.pdf
Official FDA record: K243837
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.