FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
DreaMed Advisor Pro
K Number: K191370
·
Decision Jul 18, 2019
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
4
Applicant Total
5
Review Days
57
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Basic Information
- Device Name
- DreaMed Advisor Pro
- K Number
- K191370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1358
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DreaMed Diabetes, Ltd.
- Date Received
- May 22, 2019
- Decision Date
- July 18, 2019
- 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 |
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