FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
RETINA CAMERA TRC-NW7SF MARK II
K Number: K090115
·
Decision Jun 30, 2009
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
9
Review Days
160
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Basic Information
- Device Name
- RETINA CAMERA TRC-NW7SF MARK II
- K Number
- K090115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Topcon Corp.
- Date Received
- January 21, 2009
- Decision Date
- June 30, 2009
- Product Code
- HKI
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- Y
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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| K063388 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM | Jun 22, 2007 | Substantially Equivalent |
| K041367 | TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA | Nov 5, 2004 | Substantially Equivalent |