FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
ALADDIN HW3.0
K Number: K160327
·
Decision Oct 5, 2016
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
107
Applicant Total
4
Review Days
243
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Basic Information
- Device Name
- ALADDIN HW3.0
- K Number
- K160327
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Visia Imaging S.R.L.
- Date Received
- February 5, 2016
- Decision Date
- October 5, 2016
- Product Code
- HJO
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | FDA class 2 | Ophthalmic |
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