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O-Arm O2 Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151000
510(k) Type
Traditional
Applicant
MEDTRONIC INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/6/2015
Days to Decision
113 days
Submission Type
Summary

O-Arm O2 Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151000
510(k) Type
Traditional
Applicant
MEDTRONIC INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/6/2015
Days to Decision
113 days
Submission Type
Summary