Clearance Summary
ACUSON S228, S519 & L558 TRANSDUCERS received FDA 510(k) clearance under submission number K861577, 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 1986-06-19.
- Submission: K861577
- Applicant / Sponsor: Acuson Computed Sonography
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2960
- Decision date: 1986-06-19
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.