Clearance Summary
ACUSON TV519 TRANSDUCER received FDA 510(k) clearance under submission number K864578, sponsored by Acuson Computed Sonography. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1987-03-27.
- Submission: K864578
- Applicant / Sponsor: Acuson Computed Sonography
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2960
- Decision date: 1987-03-27
Classification & Regulation
This clearance is catalogued under FDA product code HGL and 21 CFR 884.2960, within the Obstetrics/Gynecology review panel as a Class II device.