FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOWA AUTOMATED TONOMETER KT-500
K Number: K013805
·
Decision Oct 11, 2002
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
56
Applicant Total
10
Review Days
330
Basic Information
- Device Name
- KOWA AUTOMATED TONOMETER KT-500
- K Number
- K013805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- KOWA OPTIMED, INC.
- Date Received
- November 15, 2001
- Decision Date
- October 11, 2002
- 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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Other Clearances by KOWA OPTIMED, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 | Jun 17, 1996 | Substantially Equivalent |
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| K955442 | KOWA SC-1200 PHOTO SLIT LAMP SYSTEM | Jan 3, 1996 | Substantially Equivalent |
| K954780 | KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C | Dec 1, 1995 | Substantially Equivalent |
| K954781 | KOWA GENESIS HAND-HELD FUNDUS CAMERA | Dec 1, 1995 | Substantially Equivalent |
| K954782 | KOWA PORTABLE SLIT LAMP SL-14 & SL-14B | Nov 24, 1995 | Substantially Equivalent |
| K913852 | LASER FLARE METER | Feb 7, 1992 | Substantially Equivalent |
| K880920 | LASER FLARE CELL METER FC-1000 | Sep 27, 1988 | Substantially Equivalent |
| K881219 | AUTOMATIC PERIMETER, AP-340 | May 3, 1988 | Substantially Equivalent |