Clearance Summary
AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM received FDA 510(k) clearance under submission number K896356, sponsored by Esaote Biomedica Spa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-08-21.
- Submission: K896356
- Applicant / Sponsor: Esaote Biomedica Spa
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1990-08-21
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.