Clearance Summary
NMI IC received FDA 510(k) clearance under submission number K101326, sponsored by Navilyst Medical, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2010-09-02.
- Submission: K101326
- Applicant / Sponsor: Navilyst Medical, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2010-09-02
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.