Clearance Summary
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM received FDA 510(k) clearance under submission number K090957, sponsored by I2s Micro Implantable Systems, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2009-05-28.
- Submission: K090957
- Applicant / Sponsor: I2s Micro Implantable Systems, LLC
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1835
- Decision date: 2009-05-28
Classification & Regulation
This clearance is catalogued under FDA product code GWL and 21 CFR 882.1835, within the Neurology review panel as a Class II device.