Clearance Summary
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) received FDA 510(k) clearance under submission number K090608, sponsored by Minta Medical Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2010-06-14.
- Submission: K090608
- Applicant / Sponsor: Minta Medical Limited
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4725
- Decision date: 2010-06-14
Classification & Regulation
This clearance is catalogued under FDA product code GXI and 21 CFR 882.4725, within the Neurology review panel as a Class II device.