K141273 is an FDA 510(k) clearance for the WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE. This device is classified as a Accessories, Pump, Infusion (Class II - Special Controls, product code MRZ).
Submitted by Welldoc, Inc. (Baltimore, US). The FDA issued a Cleared decision on July 8, 2014, 53 days after receiving the submission on May 16, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K141273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2014 |
| Decision Date | July 08, 2014 |
| Days to Decision | 53 days |
| Submission Type | Special |
| 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 |