FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
CellChek 20 rc
K Number: K203244
·
Decision Jun 15, 2021
Classifications
1
FEI Numbers
31
Registration Numbers
32
Same Product Code
51
Applicant Total
7
Review Days
224
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Basic Information
- Device Name
- CellChek 20 rc
- K Number
- K203244
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Konan Medical, Inc.
- Date Received
- November 3, 2020
- Decision Date
- June 15, 2021
- Product Code
- NFJ
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| NFJ | System, Image Management, Ophthalmic | FDA class 2 | Radiology |
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| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K040373 | KERATO ANALYZER (EKA) | Mar 19, 2004 | Substantially Equivalent |
| K950091 | KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 | Mar 1, 1995 | Substantially Equivalent |