FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
iCare ST500 (TA04)
K Number: K241447
·
Decision Sep 27, 2024
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
7
Review Days
128
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Basic Information
- Device Name
- iCare ST500 (TA04)
- K Number
- K241447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icare Finland OY
- Date Received
- May 22, 2024
- Decision Date
- September 27, 2024
- 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 Icare Finland OY
| K Number | Device Name | ||
|---|---|---|---|
| K220852 | iCare IC200 | Oct 6, 2022 | Substantially Equivalent |
| K211355 | iCare HOME2 | Jan 25, 2022 | Substantially Equivalent |
| K200966 | Icare HOME Tonometer | May 7, 2020 | Substantially Equivalent |
| K190316 | Icare ic200 | Jan 14, 2020 | Substantially Equivalent |
| K163343 | Icare HOME tonometer | Mar 21, 2017 | Substantially Equivalent |
| K153694 | Icare ic100 | Apr 19, 2016 | Substantially Equivalent |