K234107
- 510(k) number
- K234107
- Device name
- Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
- Applicant
- Laborie Medical Technologies, Corp. NH · US
- Product code
- KLA — Monitor, Esophageal Motility, Anorectal Motility, An
- Decision date
- 2024-04-23
- Date received
- 2023-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K234107.pdf
Official FDA record: K234107
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.