DreaMed Advisor Pro
FDA 510(k) clearance DEN170043 · decided 2018-06-12
Clearance details
- K-number
- DEN170043
- Device name
- DreaMed Advisor Pro
- Applicant
- DreaMed Diabetes, Ltd.
- Decision
- Unknown
- Date received
- 2017-08-17
- Decision date
- 2018-06-12
- Days to decision
- 299 days
- Clearance type
- Direct
- Product code
- QCC
- Device class
- 2
- Regulation number
- 862.1358
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Petah Tikva, Pob 3271, IL
- Third-party review
- No
- Expedited review
- No
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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 |
| Advisor Pro Platform (K210561) | DreaMed Diabetes, Ltd. | 2021-09-28 |
| DreaMed Advisor Pro (K201476) | DreaMed Diabetes, Ltd. | 2020-08-28 |
| DreaMed Advisor Pro (K191370) | DreaMed Diabetes, Ltd. | 2019-07-18 |
Recalls involving this device
No recalls on record reference this clearance.