The following data is part of a premarket notification filed by Dreamed Diabetes Ltd. with the FDA for Advisor Pro Platform.
| Device ID | K210561 |
| 510k Number | K210561 |
| Device Name: | Advisor Pro Platform |
| Classification | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals |
| Applicant | DreaMed Diabetes Ltd. 5 Mota Gur St. Petah Tikva, IL 4952701 |
| Contact | Inbal Beinglass Peled |
| Correspondent | Inbal Beinglass Peled DreaMed Diabetes Ltd. 5 Mota Gur St. 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 | 2021-02-25 |
| Decision Date | 2021-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017735030 | K210561 | 000 |