The following data is part of a premarket notification filed by Welldoc, Inc with the FDA for Welldoc Bluestar, Welldoc Bluestar Rx.
| Device ID | K162532 |
| 510k Number | K162532 |
| Device Name: | WellDoc BlueStar, WellDoc BlueStar Rx |
| Classification | Accessories, Pump, Infusion |
| Applicant | WELLDOC, INC 10221 WINCOPIN CIRCLE SUITE 150 Columbia, MD 21044 |
| Contact | Danielle Dorfman |
| Correspondent | Danielle Dorfman 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 | 2016-09-09 |
| Decision Date | 2017-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B553BLUESTARRX510 | K162532 | 000 |
| B553BLUESTARRX610 | K162532 | 000 |
| B553BLUESTARRX570 | K162532 | 000 |
| B553BLUESTARRX560 | K162532 | 000 |
| B553OTREVEALPLUSRX150 | K162532 | 000 |
| B553BLUESTARRX550 | K162532 | 000 |
| B553OTREVEALPLUSRX140 | K162532 | 000 |
| B553BLUESTARRX540 | K162532 | 000 |
| B553BLUESTARRX530 | K162532 | 000 |
| B553OTREVEALPLUSRX120 | K162532 | 000 |
| B553OTREVEALPLUSRX130 | K162532 | 000 |
| B553BLUESTARRX420 | K162532 | 000 |
| B553BLUESTARRX500 | K162532 | 000 |
| B553BLUESTARRX620 | K162532 | 000 |