Clearance Summary
BD6000 THE OPTIMA & BD5000 BIRTHING BED received FDA 510(k) clearance under submission number K914544, sponsored by Lic Care, 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 1993-11-24.
- Submission: K914544
- Applicant / Sponsor: Lic Care, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1993-11-24
Classification & Regulation
This clearance is catalogued under FDA product code KNC and 21 CFR 884.4900, within the Obstetrics/Gynecology review panel as a Class II device.