The following data is part of a premarket notification filed by Dreamed Diabetes Ltd with the FDA for Dreamed Advisor Pro.
| Device ID | K191370 |
| 510k Number | K191370 |
| Device Name: | DreaMed Advisor Pro |
| Classification | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
| Applicant | DreaMed Diabetes Ltd 5 Mota Gur Street Petah Tikva, IL 4952701 |
| Contact | Eran Atlas |
| Correspondent | Eran J. Atlas DreaMed Diabetes Ltd 5 Mota Gur Street Petah Tikva, IL 4952701 |
| Product Code | QCC |
| CFR Regulation Number | 862.1358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-22 |
| Decision Date | 2019-07-18 |