Data / Medical devices / Finland / Icare Finland Oy
Icare Finland Oy: FDA-registered device maker in Vantaa Uusimaa, Finland, 4 510(k) clearances
Icare Finland Oy is registered with the FDA (registration 3005324856) in Vantaa Uusimaa, Finland. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005324856
- Address
- Ayritie 22, Vantaa Uusimaa, Finland, 01510
- Owner or operator
- Icare Finland Oy (10022915)
- Roles
- Manufacturer
- First device listed
- April 20, 2016
- Registered through
- 2026
- Brand names listed
- ST500 Adapter, ST500 Remote, ST500 SmartCradle, iCare CLINIC, iCare EXPORT, iCare HOME2, iCare IC100, iCare IC200 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tonometer, Ac-Powered | HKX | 2 | Manufacturer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 27, 2024 | K241447 | iCare ST500 (TA04) | HKY | Substantially Equivalent | Icare Finland OY | accessdata.fda.gov |
| October 6, 2022 | K220852 | iCare IC200 | HKY | Substantially Equivalent | Icare Finland OY | accessdata.fda.gov |
| January 25, 2022 | K211355 | iCare HOME2 | HKY | Substantially Equivalent | Icare Finland OY | accessdata.fda.gov |
| April 19, 2016 | K153694 | Icare ic100 | HKY | Substantially Equivalent | Icare Finland OY | accessdata.fda.gov |
Compare with other makers
Updated September 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.