Clearance Summary
SINGLE USE LEE ELECTRODE received FDA 510(k) clearance under submission number K912046, sponsored by Aspen Labs. 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 1992-03-05.
- Submission: K912046
- Applicant / Sponsor: Aspen Labs
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4120
- Decision date: 1992-03-05
Classification & Regulation
This clearance is catalogued under FDA product code HGI and 21 CFR 884.4120, within the Obstetrics/Gynecology review panel as a Class II device.