Clearance Summary
GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT received FDA 510(k) clearance under submission number K854555, sponsored by Gl Ultrasound , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1986-03-12.
- Submission: K854555
- Applicant / Sponsor: Gl Ultrasound , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1986-03-12
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.