FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
RETINAL CUBE
K Number: K973950
·
Decision Dec 12, 1997
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
7
Review Days
57
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Basic Information
- Device Name
- RETINAL CUBE
- K Number
- K973950
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Spectral Imaging , Ltd.
- Date Received
- October 16, 1997
- Decision Date
- December 12, 1997
- 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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