The following data is part of a premarket notification filed by Welldoc, Inc with the FDA for Welldoc Diabetesmanager System And Diabetesmanager- Rx Syste.
| Device ID | K141273 |
| 510k Number | K141273 |
| Device Name: | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE |
| Classification | Accessories, Pump, Infusion |
| Applicant | WELLDOC, INC 1501 SAINT PAUL STREET SUITE 118 Baltimore, MD 21202 |
| Contact | Divya Kallamadi |
| Correspondent | Divya Kallamadi 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 | 2014-05-16 |
| Decision Date | 2014-07-08 |
| Summary: | summary |