Clearance Summary
THE ROBOLITE received FDA 510(k) clearance under submission number K964460, sponsored by Shai Syg Motion and Innovations, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1997-01-24.
- Submission: K964460
- Applicant / Sponsor: Shai Syg Motion and Innovations, Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2100
- Decision date: 1997-01-24
Classification & Regulation
This clearance is catalogued under FDA product code JQP and 21 CFR 862.2100, within the Clinical Chemistry review panel as a Class I device.