FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Applanation tonometer AT-2
K Number: K182491
·
Decision Dec 10, 2018
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
5
Review Days
90
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Basic Information
- Device Name
- Applanation tonometer AT-2
- K Number
- K182491
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Takagi Seiko Co., Ltd.
- Date Received
- September 11, 2018
- Decision Date
- December 10, 2018
- Product Code
- HKY
- 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 |
|---|---|---|---|
| HKY | Tonometer, Manual | FDA class 2 | Ophthalmic |
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Other Clearances by Takagi Seiko Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K172728 | Applanation tonometer AT-1 | Oct 17, 2017 | Substantially Equivalent |
| K162636 | Marco Ultra M3, Marco Ultra M4 | Apr 14, 2017 | Substantially Equivalent |
| K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | May 26, 2016 | Substantially Equivalent |
| K063352 | ELLEX SLIT LAMP, MODEL 30XL | Mar 13, 2007 | Substantially Equivalent |