FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KERATO ANALYZER (EKA)
K Number: K040373
·
Decision Mar 19, 2004
Classifications
1
FEI Numbers
7
Registration Numbers
8
Same Product Code
8
Applicant Total
7
Review Days
31
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Basic Information
- Device Name
- KERATO ANALYZER (EKA)
- K Number
- K040373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Konan Medical, Inc.
- Date Received
- February 17, 2004
- Decision Date
- March 19, 2004
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQE), ordered by most recent decision date.
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SPECULAR MICROSCOPE CEM-530
FDA 510(k)
FDA Class 2
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|---|---|---|---|
| K203244 | CellChek 20 rc | Jun 15, 2021 | Substantially Equivalent |
| K191558 | Konan Specular Microscope XVII | Mar 26, 2020 | Substantially Equivalent |
| K120264 | KONAN SPECULAR MICROSCOPE XIV | Apr 11, 2012 | Substantially Equivalent |
| K081797 | IMAGE STORAGE SYSTEM, MODEL KSS-400 | Jan 22, 2009 | Substantially Equivalent |
| K062763 | NONCON ROBO PACHY F&A | Feb 22, 2008 | Substantially Equivalent |
| K950091 | KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 | Mar 1, 1995 | Substantially Equivalent |