Clearance Summary
ACUSON S328, L382, L538 & L312 TRANSDUCERS received FDA 510(k) clearance under submission number K861578, 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 1986-06-17.
- Submission: K861578
- Applicant / Sponsor: Acuson Computed Sonography
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2960
- Decision date: 1986-06-17
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.