FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
KOWA NONMYD WX
K Number: K101628
·
Decision Jan 26, 2011
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
16
Review Days
230
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Basic Information
- Device Name
- KOWA NONMYD WX
- K Number
- K101628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kowa Co. , Ltd.
- Date Received
- June 10, 2010
- Decision Date
- January 26, 2011
- 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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Other Clearances by Kowa Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K133755 | KOWA SL-17 | Mar 11, 2014 | Substantially Equivalent |
| K112330 | KOWA VX-20 | Feb 16, 2012 | Substantially Equivalent |
| K091098 | KOWAGENESIS-DF | Aug 7, 2009 | Substantially Equivalent |
| K091039 | KOWA, FM-600, MODEL LSS50 | Aug 7, 2009 | Substantially Equivalent |
| K091683 | KOWA VX-10 A | Jul 2, 2009 | Substantially Equivalent |
| K083387 | MODIFICATION TO KOWA NONMYD ALPHA-DIII | Jan 16, 2009 | Substantially Equivalent |
| K082767 | KOWA NONMYD ALPHA-DIII | Oct 21, 2008 | Substantially Equivalent |
| K080681 | KOWA GENESIS-D | Apr 4, 2008 | Substantially Equivalent |
| K063640 | KOWA SL-15 | Dec 18, 2006 | Substantially Equivalent |
| K062021 | KOWA VX-10I | Nov 1, 2006 | Substantially Equivalent |