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PENTAX Medical EPK-3000 Video Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182846
510(k) Type
Special
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/9/2019
Days to Decision
92 days
Submission Type
Summary

PENTAX Medical EPK-3000 Video Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182846
510(k) Type
Special
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/9/2019
Days to Decision
92 days
Submission Type
Summary