FDA 510(k)
FDA class 2
Unknown
🇮🇱 Israel
DreaMed Advisor Pro
K Number: DEN170043
·
Decision Jun 12, 2018
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
4
Applicant Total
5
Review Days
299
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DreaMed Advisor Pro
- K Number
- DEN170043
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 862.1358
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Applicant
- DreaMed Diabetes, Ltd.
- Date Received
- August 17, 2017
- Decision Date
- June 12, 2018
- Product Code
- QCC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QCC | Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QCC), ordered by most recent decision date.
endo.digital Platform
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Advisor Pro Platform
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DreaMed Advisor Pro
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DreaMed Advisor Pro
FDA 510(k)
FDA Class 2
·Clinical Chemistry