Clearance Summary
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C received FDA 510(k) clearance under submission number K090052, 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 2009-05-29.
- Submission: K090052
- Applicant / Sponsor: Johari Digital Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5800
- Decision date: 2009-05-29
Classification & Regulation
This clearance is catalogued under FDA product code QJQ and 21 CFR 882.5800, within the Neurology review panel as a Class II device.