The following data is part of a premarket notification filed by Welldoc, Inc with the FDA for Bluestar Rx.
| Device ID | K193654 |
| 510k Number | K193654 |
| Device Name: | BlueStar Rx |
| Classification | Accessories, Pump, Infusion |
| 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 | 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 | 2019-12-30 |
| Decision Date | 2020-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B553HLTHOPTIMIZERX120 | K193654 | 000 |
| B553202192OTC0 | K193654 | 000 |
| B553202193OTC0 | K193654 | 000 |
| B553202091OTC0 | K193654 | 000 |
| B553202092OTC0 | K193654 | 000 |
| B553202093OTC0 | K193654 | 000 |
| B553HLTHOPTIMIZER190 | K193654 | 000 |
| B553HLTHOPTIMIZER180 | K193654 | 000 |
| B553HLTHOPTIMIZER150 | K193654 | 000 |
| B553HLTHOPTIMIZERX150 | K193654 | 000 |
| B553HLTHOPTIMIZER170 | K193654 | 000 |
| B553HLTHOPTIMIZERRX170 | K193654 | 000 |
| B553HLTHOPTIMIZER160 | K193654 | 000 |
| B553HLTHOPTIMIZERRX160 | K193654 | 000 |
| B553HLTHOPTIMIZER140 | K193654 | 000 |
| B553HLTHOPTIMIZERX140 | K193654 | 000 |
| B553HLTHOPTIMIZER130 | K193654 | 000 |
| B553HLTHOPTIMIZERX130 | K193654 | 000 |
| B553202191OTC0 | K193654 | 000 |