Clearance Summary
MEDFUSION 2001 & 2010, MODEL N7215IWC received FDA 510(k) clearance under submission number K012259, sponsored by National Custom Ent., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2001-09-12.
- Submission: K012259
- Applicant / Sponsor: National Custom Ent., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2001-09-12
Classification & Regulation
This clearance is catalogued under FDA product code MRZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.