Clearance Summary
INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM received FDA 510(k) clearance under submission number DEN060002, sponsored by Inrange Systems, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2007-06-13.
- Submission: DEN060002
- Applicant / Sponsor: Inrange Systems, Inc.
- Clearance pathway: Post-NSE
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6315
- Decision date: 2007-06-13
Classification & Regulation
This clearance is catalogued under FDA product code NZH and 21 CFR 880.6315, within the General Hospital review panel as a Class II device.