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hyperion X5, NewTom GO, X-RADiUS COMPACT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200688
510(k) Type
Traditional
Applicant
CEFLA S.C.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
4/9/2020
Days to Decision
24 days
Submission Type
Summary

hyperion X5, NewTom GO, X-RADiUS COMPACT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200688
510(k) Type
Traditional
Applicant
CEFLA S.C.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
4/9/2020
Days to Decision
24 days
Submission Type
Summary