K231875
- 510(k) number
- K231875
- Device name
- Vaginal Tactile Ultrasound Imager
- Applicant
- Advanced Tactile Imaging, Inc. NJ · US
- Product code
- HIR — Perineometer
- Decision date
- 2024-02-22
- Date received
- 2023-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231875.pdf
Official FDA record: K231875
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.