K190013 is an FDA 510(k) clearance for the WellDoc BlueStar. This device is classified as a Accessories, Pump, Infusion (Class II - Special Controls, product code MRZ).
Submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on November 4, 2019, 305 days after receiving the submission on January 3, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K190013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2019 |
| Decision Date | November 04, 2019 |
| Days to Decision | 305 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MRZ - Accessories, Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |