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Fujifilm Duodenoscope Model ED-530XT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152257
510(k) Type
Traditional
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/21/2017
Days to Decision
711 days
Submission Type
Summary

Fujifilm Duodenoscope Model ED-530XT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152257
510(k) Type
Traditional
Applicant
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/21/2017
Days to Decision
711 days
Submission Type
Summary