The following data is part of a De Novo classification by Dreamed Diabetes, Ltd. with the FDA for Dreamed Advisor Pro.
| DeNovo ID | DEN170043 |
| Device Name: | DreaMed Advisor Pro |
| Classification | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
| Applicant | DreaMed Diabetes, Ltd. 3 Shimshon St. Petah Tikva, Pob 3271, IL 4952701 |
| Contact | Eran Atlas |
| Product Code | QCC |
| CFR Regulation Number | 862.1358 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Clinical Chemistry |
| Classification Advisory | Clinical Chemistry |
| Type | Direct |
| Date Received | 2017-08-17 |
| Decision Date | 2018-06-12 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017735016 | DEN170043 | 000 |