The following data is part of a premarket notification filed by Welldoc, Inc. with the FDA for Welldoc Bluestar.
| Device ID | K190013 |
| 510k Number | K190013 |
| Device Name: | WellDoc BlueStar |
| Classification | Accessories, Pump, Infusion |
| Applicant | WellDoc, Inc. 10221 Wincopin Circle, Suite 150 Columbia, MD 21044 |
| Contact | Caroline York |
| Correspondent | Caroline York WellDoc, Inc. 10221 Wincopin Circle, Suite 150 Columbia, MD 21044 |
| Product Code | MRZ |
| Subsequent Product Code | LNX |
| Subsequent Product Code | NDC |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-03 |
| Decision Date | 2019-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B553PLUSRX100 | K190013 | 000 |
| B553TEMPOSMART110 | K190013 | 000 |
| B553TEMPOINSIGHTS100 | K190013 | 000 |
| B553TEMPOSMART100 | K190013 | 000 |
| B553PULSE100 | K190013 | 000 |
| B553PULSERX100 | K190013 | 000 |
| B553WELLDOC120 | K190013 | 000 |
| B553WELLDOCRX120 | K190013 | 000 |
| B553HLTHOPTIMIZER100 | K190013 | 000 |
| B553HLTHOPTIMIZERRX100 | K190013 | 000 |
| B553PLUS120 | K190013 | 000 |
| B553PLUSRX120 | K190013 | 000 |
| B553PLUS110 | K190013 | 000 |
| B553PLUSRX110 | K190013 | 000 |
| B553PLUS100 | K190013 | 000 |
| B553TEMPOINSIGHTS110 | K190013 | 000 |