The following data is part of a premarket notification filed by Welldoc, Inc with the FDA for Bluestar Rx.
| Device ID | K203434 |
| 510k Number | K203434 |
| Device Name: | BlueStar Rx |
| Classification | Calculator, Drug Dose |
| Applicant | WellDoc, Inc 10221 Wincopin Circle, Suite 150 Columbia, MD 21044 |
| Contact | Sabyasachi Roy |
| Correspondent | Sabyasachi Roy WellDoc, Inc 10221 Wincopin Circle, Suite 150 Columbia, MD 21044 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-23 |
| Decision Date | 2021-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B553BLUESTAR710 | K203434 | 000 |
| B553HEALTHFIRSTRX200 | K203434 | 000 |
| B553HEALTHFIRST200 | K203434 | 000 |
| B553BLUESTAR720 | K203434 | 000 |
| B553202056RX0 | K203434 | 000 |
| B553202054RX0 | K203434 | 000 |
| B553202053OTC0 | K203434 | 000 |
| B553202052RX0 | K203434 | 000 |
| B553202051OTC0 | K203434 | 000 |
| B553LCDIABETESRX110 | K203434 | 000 |
| B553LCDIABETES110 | K203434 | 000 |
| B553CCDIABETESRX110 | K203434 | 000 |
| B553WELLDOC200 | K203434 | 000 |
| B553WELLDOCRX200 | K203434 | 000 |
| B553WELLDOC140 | K203434 | 000 |
| B553HEALTHFIRSTRX1007 | K203434 | 000 |
| B553HEALTHFIRST100 | K203434 | 000 |
| B553WELLDOCRX130 | K203434 | 000 |
| B553WELLDOC130 | K203434 | 000 |
| B553HEALTHFIRSTRX1108 | K203434 | 000 |
| B553HEALTHFIRST110 | K203434 | 000 |
| B553CCDIABETESRX100 | K203434 | 000 |
| B553CCDIABETES100 | K203434 | 000 |
| B553LCDIABETESRX100 | K203434 | 000 |
| B553LCDIABETES100 | K203434 | 000 |
| B553WELLDOCRX140 | K203434 | 000 |
| B553CCDIABETES110 | K203434 | 000 |