Clearance Summary
ELMED LBC 50-P received FDA 510(k) clearance under submission number K926517, sponsored by Elmed, Inc.. 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 1994-11-15.
- Submission: K926517
- Applicant / Sponsor: Elmed, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4150
- Decision date: 1994-11-15
Classification & Regulation
This clearance is catalogued under FDA product code HIN and 21 CFR 884.4150, within the Obstetrics/Gynecology review panel as a Class II device.