Clearance Summary
RUB E-Z received FDA 510(k) clearance under submission number K854396, sponsored by E-Z Instruments Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1986-05-08.
- Submission: K854396
- Applicant / Sponsor: E-Z Instruments Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1410
- Decision date: 1986-05-08
Classification & Regulation
This clearance is catalogued under FDA product code GYA and 21 CFR 882.1410, within the Neurology review panel as a Class I device.