Clearance Summary
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 received FDA 510(k) clearance under submission number K082011, 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 2008-11-28.
- Submission: K082011
- Applicant / Sponsor: Bio-Medical Research, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2008-11-28
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.