K240544
- 510(k) number
- K240544
- Device name
- Epitomee
- Applicant
- Epitomee Medical , Ltd. IL
- Product code
- QFQ — Ingested, Transient, Space Occupying Device For Weig
- Decision date
- 2024-09-13
- Date received
- 2024-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240544.pdf
Official FDA record: K240544
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.