510(k) K060298
K060298 is an FDA 510(k) premarket notification submitted by Vocel for the device "PILL PHONE". The FDA issued a decision of Substantially Equivalent on March 29, 2006. The device falls under product code NXQ (Reminder, Medication), a Class I device regulated under 21 CFR 890.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2006
- Date Received
- February 6, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reminder, Medication
- Device Class
- Class I
- Regulation Number
- 890.5050
- Review Panel
- HO
- Submission Type
A medication reminder is a device intended for medical purposes to provide alerts to patients or healthcare providers for pre-determined medication dosing schedules. The device may incorporate wireless communication.