Clearance Summary
LORRAINE DSL LABOR & DELIVERY BED received FDA 510(k) clearance under submission number K842962, sponsored by Pulley-Kellam Co., 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 1984-09-25.
- Submission: K842962
- Applicant / Sponsor: Pulley-Kellam Co., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1984-09-25
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.