FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISUCAM PRO NM
K Number: K052268
·
Decision Nov 2, 2005
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
45
Review Days
75
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Basic Information
- Device Name
- VISUCAM PRO NM
- K Number
- K052268
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec, AG
- Date Received
- August 19, 2005
- Decision Date
- November 2, 2005
- 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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