Clearance Summary
CENTRAL STATION REPEATER (MODEL 8032A) received FDA 510(k) clearance under submission number K760968, 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 1976-12-17.
- Submission: K760968
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2600
- Decision date: 1976-12-17
Classification & Regulation
This clearance is catalogued under FDA product code KXN and 21 CFR 884.2600, within the Obstetrics/Gynecology review panel as a Class II device.