The following data is part of a premarket notification filed by Welldoc, Inc with the FDA for Diabetesmanager System, Diabetesmanager-rx System Model Version 1.1.
| Device ID | K100066 |
| 510k Number | K100066 |
| Device Name: | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 |
| Classification | Medical Computers And Software |
| Applicant | WELLDOC, INC 1501 SAINT PAUL STREET SUITE 118 Baltimore, MD 21202 |
| Contact | Malinda Peeples |
| Correspondent | Malinda Peeples WELLDOC, INC 1501 SAINT PAUL STREET SUITE 118 Baltimore, MD 21202 |
| Product Code | LNX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-11 |
| Decision Date | 2010-07-15 |
| Summary: | summary |