K242304
- 510(k) number
- K242304
- Device name
- RED
- Applicant
- Neuraxis, Inc. IN · US
- Product code
- KLA — Monitor, Esophageal Motility, Anorectal Motility, An
- Decision date
- 2024-12-06
- Date received
- 2024-08-05
- 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: K242304.pdf
Official FDA record: K242304
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.