Advisor Pro Platform
FDA 510(k) clearance K210561 · decided 2021-09-28
Clearance details
- K-number
- K210561
- Device name
- Advisor Pro Platform
- Applicant
- DreaMed Diabetes, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-25
- Decision date
- 2021-09-28
- Days to decision
- 215 days
- Clearance type
- Traditional
- Product code
- QCC
- Device class
- 2
- Regulation number
- 862.1358
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Petah Tikva, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch DreaMed Diabetes
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| endo.digital Platform (K232722) | DreaMed Diabetes, Ltd. | 2023-10-03 |
| DreaMed Advisor Pro (K201476) | DreaMed Diabetes, Ltd. | 2020-08-28 |
| DreaMed Advisor Pro (K191370) | DreaMed Diabetes, Ltd. | 2019-07-18 |
| DreaMed Advisor Pro (DEN170043) | DreaMed Diabetes, Ltd. | 2018-06-12 |
Recalls involving this device
No recalls on record reference this clearance.