Last synced on 27 June 2025 at 11:06 pm

iCare HOME2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211355
510(k) Type
Traditional
Applicant
Icare Finland Oy
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
1/25/2022
Days to Decision
267 days
Submission Type
Summary

iCare HOME2

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211355
510(k) Type
Traditional
Applicant
Icare Finland Oy
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
1/25/2022
Days to Decision
267 days
Submission Type
Summary