K243788
- 510(k) number
- K243788
- Device name
- IceCap product line
- Applicant
- Bioserenity Medical Devices Group FR
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2025-03-13
- Date received
- 2024-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K243788.pdf
Official FDA record: K243788
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.