Clearance Summary
DIAMOND SETUP 2000 received FDA 510(k) clearance under submission number K032886, sponsored by K&S Assoc., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-01-09.
- Submission: K032886
- Applicant / Sponsor: K&S Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2004-01-09
Classification & Regulation
This clearance is catalogued under FDA product code LHN and 21 CFR 892.5050, within the Radiology review panel as a Class II device.