K240007
- 510(k) number
- K240007
- Device name
- Solar Compact (G4-1)
- Applicant
- Laborie Medical Technologies, Corp. NH · US
- Product code
- FFX — System, Gastrointestinal Motility (Electrical)
- Decision date
- 2024-05-06
- Date received
- 2024-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240007.pdf
Official FDA record: K240007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.