510(k) K210561
- Device
- Advisor Pro Platform
- Applicant
- DreaMed Diabetes Ltd.
- 510(k) number
- K210561
- Product code
- QCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-28
- Date received
- 2021-02-25
- Regulation
- 862.1358
- Classification name
- Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Inbal Beinglass Peled
- Address
- 5 Mota Gur St. Petah Tikva IL 4952701 4952701
FDA Registration Numbers#
- 3013922904
Source Documents#
Other 510(k) Records For Product Code QCC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232722 | endo.digital Platform | DreaMed Diabetes, Ltd. | 2023-10-03 |
| K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020-08-28 |
| K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019-07-18 |
| DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018-06-12 |
Legacy Summary#
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FDA Review#
Decision Summary