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 |