Clearance Summary
LABOR-DELIVERY STRETCH/BED received FDA 510(k) clearance under submission number K861030, 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 1986-04-23.
- Submission: K861030
- Applicant / Sponsor: Adel Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1986-04-23
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.