Clearance Summary
16 CH MULTIPURPOSE COIL VARIETY received FDA 510(k) clearance under submission number K140252, sponsored by Noras Rontgen-Und Medizintechnik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-05-08.
- Submission: K140252
- Applicant / Sponsor: Noras Rontgen-Und Medizintechnik GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2014-05-08
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.