Clearance Summary
TILT 10, CATALOG #S-2600 received FDA 510(k) clearance under submission number K771942, sponsored by Affiliated Hospital Products, 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 1977-10-27.
- Submission: K771942
- Applicant / Sponsor: Affiliated Hospital Products, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1977-10-27
Classification & Regulation
This clearance is catalogued under FDA product code HDD and 21 CFR 884.4900, within the Obstetrics/Gynecology review panel as a Class II device.