Clearance Summary
DANTEC KEYPOINT received FDA 510(k) clearance under submission number K944547, sponsored by Mckenna & Cuneo. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1995-09-19.
- Submission: K944547
- Applicant / Sponsor: Mckenna & Cuneo
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 1995-09-19
Classification & Regulation
This clearance is catalogued under FDA product code GWF and 21 CFR 882.1870, within the Neurology review panel as a Class II device.