Clearance Summary
SPIRAL SCALP ELECTRODE, 14499A received FDA 510(k) clearance under submission number K771553, sponsored by Hewlett-Packard Co.. 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 1977-08-25.
- Submission: K771553
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2675
- Decision date: 1977-08-25
Classification & Regulation
This clearance is catalogued under FDA product code HGP and 21 CFR 884.2675, within the Obstetrics/Gynecology review panel as a Class II device.