Clearance Summary
SERIES 50XM received FDA 510(k) clearance under submission number K954351, sponsored by Hewlett-Packard GmbH. 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 1996-03-08.
- Submission: K954351
- Applicant / Sponsor: Hewlett-Packard GmbH
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1996-03-08
Classification & Regulation
This clearance is catalogued under FDA product code HGM and 21 CFR 884.2740, within the Obstetrics/Gynecology review panel as a Class II device.