Clearance Summary
CAROLINA X-RAY CO. SIMPLAFLOAT TABLE received FDA 510(k) clearance under submission number K842614, sponsored by Carolina X-Ray Co., 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 1984-08-08.
- Submission: K842614
- Applicant / Sponsor: Carolina X-Ray Co., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1984-08-08
Classification & Regulation
This clearance is catalogued under FDA product code IXQ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.