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PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220465
510(k) Type
Traditional
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/16/2022
Days to Decision
272 days
Submission Type
Summary

PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220465
510(k) Type
Traditional
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/16/2022
Days to Decision
272 days
Submission Type
Summary