FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Applanation Tonometer HT-5000
K Number: K232143
·
Decision Oct 23, 2023
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
6
Review Days
96
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Basic Information
- Device Name
- Applanation Tonometer HT-5000
- K Number
- K232143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huvitz Co., Ltd.
- Date Received
- July 19, 2023
- Decision Date
- October 23, 2023
- 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 Huvitz Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K202097 | Fundus Camera | Feb 2, 2021 | Substantially Equivalent |
| K191615 | Huvitz Imaging System | Jul 18, 2019 | Substantially Equivalent |
| K161829 | Huvitz Imaging System | Apr 6, 2017 | Substantially Equivalent |
| K093639 | SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 | Dec 3, 2009 | Substantially Equivalent |
| K073190 | SLIT LAMP | Jan 11, 2008 | Substantially Equivalent |