Last synced on 6 December 2024 at 11:05 pm

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K214084
510(k) Type
Special
Applicant
CEFLA S.C.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
1/20/2022
Days to Decision
24 days
Submission Type
Summary

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K214084
510(k) Type
Special
Applicant
CEFLA S.C.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
1/20/2022
Days to Decision
24 days
Submission Type
Summary