Clearance Summary
MEDICAL DIAG. ULTRASOUND INSTR. 77065 received FDA 510(k) clearance under submission number K842897, sponsored by Hewlett-Packard Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1984-09-25.
- Submission: K842897
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1984-09-25
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.