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ASPIRE HD PLUS, ASPIRE HD-S

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121674
510(k) Type
Traditional
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/2012
Days to Decision
107 days
Submission Type
Summary

ASPIRE HD PLUS, ASPIRE HD-S

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121674
510(k) Type
Traditional
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/2012
Days to Decision
107 days
Submission Type
Summary