FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
IRI INTEGRATED RETINAL IMAGER
K Number: K062295
·
Decision Oct 20, 2006
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
4
Review Days
74
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Basic Information
- Device Name
- IRI INTEGRATED RETINAL IMAGER
- K Number
- K062295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medivision Medical Imaging, Ltd.
- Date Received
- August 7, 2006
- Decision Date
- October 20, 2006
- Product Code
- HKI
- 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 |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
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