Clearance Summary
CONDUCTIVE GEL FOR ULTRASOUND received FDA 510(k) clearance under submission number K002832, sponsored by Skylark Device & Systems Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-08-06.
- Submission: K002832
- Applicant / Sponsor: Skylark Device & Systems Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1275
- Decision date: 2001-08-06
Classification & Regulation
This clearance is catalogued under FDA product code GYB and 21 CFR 882.1275, within the Neurology review panel as a Class II device.