Clearance Summary
CAT. NO. S-5300-E BIRTHING BED received FDA 510(k) clearance under submission number K852171, sponsored by Shampaine/Wilson. 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 1985-08-30.
- Submission: K852171
- Applicant / Sponsor: Shampaine/Wilson
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1985-08-30
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.