Clearance Summary
INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S received FDA 510(k) clearance under submission number K011155, sponsored by Ibt, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-07-12.
- Submission: K011155
- Applicant / Sponsor: Ibt, Inc.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 2001-07-12
Classification & Regulation
This clearance is catalogued under FDA product code KXK and 21 CFR 892.5730, within the Radiology review panel as a Class II device.