FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IFUSION
K Number: K130656
·
Decision Jul 3, 2013
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
16
Review Days
113
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Basic Information
- Device Name
- IFUSION
- K Number
- K130656
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optovue, Inc.
- Date Received
- March 12, 2013
- Decision Date
- July 3, 2013
- 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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