The following data is part of a premarket notification filed by Welldoc, Inc with the FDA for Welldoc Bluestar (welldoc Diabetesmanager System And Diabetesmanager-rx System.
Device ID | K162225 |
510k Number | K162225 |
Device Name: | WellDoc BlueStar (WellDoc DiabetesManager System And DiabetesManager-Rx System |
Classification | Accessories, Pump, Infusion |
Applicant | WellDoc, Inc 10221 Wincopin Circle Suite 150 Columbia, MD 21044 |
Contact | Michele Livingston |
Correspondent | Danielle Dorfman WellDoc, Inc 10221 Wincopin Circle Suite 150 Columbia, MD 21044 |
Product Code | MRZ |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-08 |
Decision Date | 2016-11-22 |
Summary: | summary |