Clearance Summary
GL ULTRASOUND Z/SL 8300 received FDA 510(k) clearance under submission number K843205, 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 1985-02-25.
- Submission: K843205
- Applicant / Sponsor: Gl Ultrasound , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1985-02-25
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.