Clearance Summary
SENSITESTER received FDA 510(k) clearance under submission number K871167, sponsored by Dexin Pty. , 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 1987-04-01.
- Submission: K871167
- Applicant / Sponsor: Dexin Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1750
- Decision date: 1987-04-01
Classification & Regulation
This clearance is catalogued under FDA product code GWY and 21 CFR 882.1750, within the Neurology review panel as a Class I device.