Clearance Summary
ActTrust received FDA 510(k) clearance under submission number K151784, sponsored by Condor Instruments Ltda. - Epp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-05-25.
- Submission: K151784
- Applicant / Sponsor: Condor Instruments Ltda. - Epp
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 2016-05-25
Classification & Regulation
This clearance is catalogued under FDA product code LEL and 21 CFR 882.5050, within the Neurology review panel as a Class II device.