Last synced on 25 January 2026 at 3:41 am

NuEra Tight RF Family

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223856
510(k) Type
Traditional
Applicant
Bios S.R.L.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
8/11/2023
Days to Decision
231 days
Submission Type
Summary

NuEra Tight RF Family

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223856
510(k) Type
Traditional
Applicant
Bios S.R.L.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
8/11/2023
Days to Decision
231 days
Submission Type
Summary