Last synced on 2 December 2022 at 11:04 pm

PENTAX Medical ED34-i10T, Video Duodenoscope

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163614
510(k) Type
Traditional
Applicant
PENTAX Medical
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/20/2017
Days to Decision
272 days
Submission Type
Summary

PENTAX Medical ED34-i10T, Video Duodenoscope

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163614
510(k) Type
Traditional
Applicant
PENTAX Medical
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/20/2017
Days to Decision
272 days
Submission Type
Summary