FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
KOWA KT-800
K Number: K053444
·
Decision Jun 9, 2006
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
16
Review Days
182
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Basic Information
- Device Name
- KOWA KT-800
- K Number
- K053444
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kowa Co. , Ltd.
- Date Received
- December 9, 2005
- Decision Date
- June 9, 2006
- Product Code
- HKX
- 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 |
|---|---|---|---|
| HKX | Tonometer, Ac-Powered | FDA class 2 | Ophthalmic |
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|---|---|---|---|
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| K101628 | KOWA NONMYD WX | Jan 26, 2011 | 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 |