Clearance Summary
VIBROTACTILE TESTER, MODEL NO. VTT-100 received FDA 510(k) clearance under submission number K921560, sponsored by Topical Testing, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1992-10-30.
- Submission: K921560
- Applicant / Sponsor: Topical Testing, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1200
- Decision date: 1992-10-30
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.