FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECULAR MICROSCOPE CEM-530
K Number: K130565
·
Decision Nov 27, 2013
Classifications
1
FEI Numbers
8
Registration Numbers
9
Same Product Code
8
Applicant Total
13
Review Days
268
Basic Information
- Device Name
- SPECULAR MICROSCOPE CEM-530
- K Number
- K130565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NIDEK CO., LTD.
- Date Received
- March 4, 2013
- Decision Date
- November 27, 2013
- Product Code
- NQE
- 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 |
|---|---|---|---|
| NQE | Microscope, Specular | FDA class 2 | Ophthalmic |
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| K111493 | NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI | Jul 27, 2011 | Substantially Equivalent |