FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL RETINAL CAMERA, CR-1 MARK II
K Number: K090466
·
Decision Mar 23, 2009
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
43
Review Days
30
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Basic Information
- Device Name
- DIGITAL RETINAL CAMERA, CR-1 MARK II
- K Number
- K090466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Canon, Inc.
- Date Received
- February 21, 2009
- Decision Date
- March 23, 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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