K112370 is an FDA 510(k) clearance for the WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM. 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 October 14, 2011, 58 days after receiving the submission on August 17, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K112370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2011 |
| Decision Date | October 14, 2011 |
| Days to Decision | 58 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MRZ - Accessories, Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |