Clearance Summary
HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS received FDA 510(k) clearance under submission number K884395, 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 1989-01-10.
- Submission: K884395
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1989-01-10
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.