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Arterys Software v2.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162513
510(k) Type
Traditional
Applicant
ARTERYS INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/28/2016
Days to Decision
50 days
Submission Type
Summary

Arterys Software v2.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162513
510(k) Type
Traditional
Applicant
ARTERYS INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/28/2016
Days to Decision
50 days
Submission Type
Summary