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EPX-4440HD and EPX-4400HD with FICE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150221
510(k) Type
Traditional
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/2015
Days to Decision
244 days
Submission Type
Summary

EPX-4440HD and EPX-4400HD with FICE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150221
510(k) Type
Traditional
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/2015
Days to Decision
244 days
Submission Type
Summary