510(k) K103009
K103009 is an FDA 510(k) premarket notification submitted by Senticare, Inc. for the device "SENTICARE PILLSTATION". The FDA issued a decision of Substantially Equivalent on January 28, 2011. 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
- January 28, 2011
- Date Received
- October 12, 2010
- 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.