Clearance Summary
SpringTMS received FDA 510(k) clearance under submission number K182976, sponsored by Eneura®, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2019-02-25.
- Submission: K182976
- Applicant / Sponsor: Eneura®, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5808
- Decision date: 2019-02-25
Classification & Regulation
This clearance is catalogued under FDA product code OKP and 21 CFR 882.5808, within the Neurology review panel as a Class II device.