Clearance Summary
STOCKERT NEURO N50, MODEL12267 received FDA 510(k) clearance under submission number K070336, sponsored by Stockert GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-06-14.
- Submission: K070336
- Applicant / Sponsor: Stockert GmbH
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4400
- Decision date: 2007-06-14
Classification & Regulation
This clearance is catalogued under FDA product code GXD and 21 CFR 882.4400, within the Neurology review panel as a Class II device.