Clearance Summary
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 received FDA 510(k) clearance under submission number K101372, sponsored by Baylis Medical Co., Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2010-08-10.
- Submission: K101372
- Applicant / Sponsor: Baylis Medical Co., Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4725
- Decision date: 2010-08-10
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.