Last synced on 19 July 2024 at 11:05 pm

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213579
510(k) Type
Traditional
Applicant
FONA S.r.l
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
3/2/2022
Days to Decision
112 days
Submission Type
Summary

Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213579
510(k) Type
Traditional
Applicant
FONA S.r.l
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
3/2/2022
Days to Decision
112 days
Submission Type
Summary