Clearance Summary
MOSFET AUTOSENSE, MODEL TN-RD-60 received FDA 510(k) clearance under submission number K013279, sponsored by Thomson & Nielsen Electronics, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-10-18.
- Submission: K013279
- Applicant / Sponsor: Thomson & Nielsen Electronics, Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2001-10-18
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.