Clearance Summary
TSA 2001 THERMAL SENSORY ANALYZER received FDA 510(k) clearance under submission number K922052, sponsored by Medoc Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1993-10-21.
- Submission: K922052
- Applicant / Sponsor: Medoc Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1200
- Decision date: 1993-10-21
Classification & Regulation
This clearance is catalogued under FDA product code LQW and 21 CFR 882.1200, within the Neurology review panel as a Class I device.