510(k) K162225
K162225 is an FDA 510(k) premarket notification submitted by Welldoc, Inc. for the device "WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System". The FDA issued a decision of Substantially Equivalent on November 22, 2016. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Welldoc, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2016
- Date Received
- August 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type