Clearance Summary
TAYLOR NEUROLOGICAL HAMMER received FDA 510(k) clearance under submission number K791337, sponsored by Amdia Medical Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1979-08-03.
- Submission: K791337
- Applicant / Sponsor: Amdia Medical Products
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1700
- Decision date: 1979-08-03
Classification & Regulation
This clearance is catalogued under FDA product code GWZ and 21 CFR 882.1700, within the Neurology review panel as a Class I device.