Clearance Summary
ISOSEED received FDA 510(k) clearance under submission number K140849, sponsored by Eckert & Ziegler Bebig GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-07-02.
- Submission: K140849
- Applicant / Sponsor: Eckert & Ziegler Bebig GmbH
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 2014-07-02
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.