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Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151668
510(k) Type
Traditional
Applicant
ESAOTE S.P.A.
Country
Italy
FDA Decision
Substantially Equivalent
Decision Date
9/8/2015
Days to Decision
81 days
Submission Type
Summary