The following data is part of a premarket notification filed by Welldoc, Inc with the FDA for Welldoc Diabetes Manager System And Diabetes Manager Rx System.
| Device ID | K112370 |
| 510k Number | K112370 |
| Device Name: | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM |
| Classification | Accessories, Pump, Infusion |
| Applicant | WELLDOC, INC 1501 SAINT PAUL STREET SUITE 118 Baltimore, MD 21202 |
| Contact | Lauren Bronich-hall |
| Correspondent | Lauren Bronich-hall WELLDOC, INC 1501 SAINT PAUL STREET SUITE 118 Baltimore, MD 21202 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-17 |
| Decision Date | 2011-10-14 |