Clearance Summary
JEOL MODEL #JTG-500M received FDA 510(k) clearance under submission number K823041, sponsored by Jeol. 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 1982-11-24.
- Submission: K823041
- Applicant / Sponsor: Jeol
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.2980
- Decision date: 1982-11-24
Classification & Regulation
This clearance is catalogued under FDA product code IYM and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class III device.