Clearance Summary
TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO received FDA 510(k) clearance under submission number K080234, sponsored by Teratech Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-02-14.
- Submission: K080234
- Applicant / Sponsor: Teratech Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2008-02-14
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.