Clearance Summary
BIO-STIM KIT received FDA 510(k) clearance under submission number K050174, 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 2005-09-07.
- Submission: K050174
- Applicant / Sponsor: Skylark Device & Systems Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2005-09-07
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.