Clearance Summary
SD5 & SD6 Ultrasonic Tabletop Doppler received FDA 510(k) clearance under submission number K153475, sponsored by Edan Instruments, Inc.. 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 2016-01-29.
- Submission: K153475
- Applicant / Sponsor: Edan Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 2016-01-29
Classification & Regulation
This clearance is catalogued under FDA product code KNG and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.