Clearance Summary
NT MEDITENS PLUS, TYPE 290 received FDA 510(k) clearance under submission number K014020, sponsored by Bio-Medical Research, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-07-11.
- Submission: K014020
- Applicant / Sponsor: Bio-Medical Research, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2002-07-11
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.