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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
K190496
510(k) Type
Traditional
Applicant
CEFLA S.C.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
4/24/2019
Days to Decision
55 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
K190496
510(k) Type
Traditional
Applicant
CEFLA S.C.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
4/24/2019
Days to Decision
55 days
Submission Type
Summary