Clearance Summary
SKI 5000 received FDA 510(k) clearance under submission number K812646, sponsored by Smithkline Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-11-16.
- Submission: K812646
- Applicant / Sponsor: Smithkline Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2330
- Decision date: 1981-11-16
Classification & Regulation
This clearance is catalogued under FDA product code DXK and 21 CFR 870.2330, within the Cardiovascular review panel as a Class II device.