Clearance Summary
SONICAID ONE received FDA 510(k) clearance under submission number K023618, sponsored by Oxford Instruments Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2003-01-22.
- Submission: K023618
- Applicant / Sponsor: Oxford Instruments Medical , Ltd.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2003-01-22
Classification & Regulation
This clearance is catalogued under FDA product code HGM and 21 CFR 884.2740, within the Obstetrics/Gynecology review panel as a Class II device.