Clearance Summary
INFREX received FDA 510(k) clearance under submission number K060246, sponsored by Johari Digital Healthcare , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-05-05.
- Submission: K060246
- Applicant / Sponsor: Johari Digital Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2006-05-05
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.