Clearance Summary
GSA GENITO SENSORY ANALYZER received FDA 510(k) clearance under submission number K010981, sponsored by Medoc Ltd. Advanced Medical Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-09-20.
- Submission: K010981
- Applicant / Sponsor: Medoc Ltd. Advanced Medical Systems
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1200
- Decision date: 2001-09-20
Classification & Regulation
This clearance is catalogued under FDA product code LLN and 21 CFR 882.1200, within the Neurology review panel as a Class I device.