Clearance Summary
SDS-4I received FDA 510(k) clearance under submission number K034005, sponsored by Skylark Device & Systems Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2004-11-18.
- Submission: K034005
- Applicant / Sponsor: Skylark Device & Systems Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2004-11-18
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.