Clearance Summary
DE48-PLUS received FDA 510(k) clearance under submission number K123915, sponsored by Grass Technologies, an Astro-Med, Inc. Product Gro. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-04-24.
- Submission: K123915
- Applicant / Sponsor: Grass Technologies, an Astro-Med, Inc. Product Gro
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2013-04-24
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.