Clearance Summary
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT received FDA 510(k) clearance under submission number K910426, sponsored by Shimadzu Medical Systems. 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 1991-06-06.
- Submission: K910426
- Applicant / Sponsor: Shimadzu Medical Systems
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2225
- Decision date: 1991-06-06
Classification & Regulation
This clearance is catalogued under FDA product code HEM and 21 CFR 884.2225, within the Obstetrics/Gynecology review panel as a Class II device.