Clearance Summary
CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS received FDA 510(k) clearance under submission number K963065, sponsored by Shantou Institute of Ultrasonic Instuments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-05-29.
- Submission: K963065
- Applicant / Sponsor: Shantou Institute of Ultrasonic Instuments
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1997-05-29
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.