FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
NON-CONTACT TONOMETER, MODEL FT-1000
K Number: K073087
·
Decision Nov 18, 2008
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
5
Review Days
383
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Basic Information
- Device Name
- NON-CONTACT TONOMETER, MODEL FT-1000
- K Number
- K073087
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tomey Corporation
- Date Received
- November 1, 2007
- Decision Date
- November 18, 2008
- 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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| K171313 | EM-4000 Specular Microscope | Jan 19, 2018 | Substantially Equivalent |