Clearance Summary
SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS received FDA 510(k) clearance under submission number K921863, sponsored by Hewlett-Packard Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1992-09-28.
- Submission: K921863
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1240
- Decision date: 1992-09-28
Classification & Regulation
This clearance is catalogued under FDA product code GXW and 21 CFR 882.1240, within the Neurology review panel as a Class II device.