510(k) DEN060002
DEN060002 is an FDA 510(k) premarket notification submitted by Inrange Systems, Inc. for the device "INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM". The FDA issued a decision of De Novo Granted on June 13, 2007. The device falls under product code NZH (Medication Management System, Remote), a Class II device regulated under 21 CFR 880.6315. Inrange Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 13, 2007
- Date Received
- September 21, 2006
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Medication Management System, Remote
- Device Class
- Class II
- Regulation Number
- 880.6315
- Review Panel
- HO
- Submission Type
A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to the patient when the prescribed medications are due to be taken; To release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command; And to provide to the medical provider a history of the event. The system is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic.