Clearance Summary
LABOR/DELIVERY/RECOVERY BED LDR-600 received FDA 510(k) clearance under submission number K833321, sponsored by Adel 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 1983-11-14.
- Submission: K833321
- Applicant / Sponsor: Adel Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1983-11-14
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.