Clearance Summary
ALPHA DETECTOR received FDA 510(k) clearance under submission number K800319, sponsored by M.O.E Electronics Research & Prod.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1980-03-03.
- Submission: K800319
- Applicant / Sponsor: M.O.E Electronics Research & Prod.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 1980-03-03
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.