Clearance Summary
ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP. received FDA 510(k) clearance under submission number K874861, sponsored by Acuson Computed Sonography. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-05-11.
- Submission: K874861
- Applicant / Sponsor: Acuson Computed Sonography
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2120
- Decision date: 1988-05-11
Classification & Regulation
This clearance is catalogued under FDA product code DPT and 21 CFR 870.2120, within the Cardiovascular review panel as a Class II device.