FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K Number: K862323
·
Decision Aug 21, 1986
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
48
Review Days
63
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Basic Information
- Device Name
- CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
- K Number
- K862323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Canon USA, Inc.
- Date Received
- June 19, 1986
- Decision Date
- August 21, 1986
- 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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