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Pentax Medical Video Duodenoscope ED32-i10

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202365
510(k) Type
Traditional
Applicant
Pentax of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/1/2021
Days to Decision
225 days
Submission Type
Summary

Pentax Medical Video Duodenoscope ED32-i10

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202365
510(k) Type
Traditional
Applicant
Pentax of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/1/2021
Days to Decision
225 days
Submission Type
Summary