Clearance Summary
TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE received FDA 510(k) clearance under submission number K992071, sponsored by Ron-Tech Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1999-08-27.
- Submission: K992071
- Applicant / Sponsor: Ron-Tech Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1999-08-27
Classification & Regulation
This clearance is catalogued under FDA product code HDC and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.