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PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210485
510(k) Type
Traditional
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/13/2021
Days to Decision
83 days
Submission Type
Summary

PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210485
510(k) Type
Traditional
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/13/2021
Days to Decision
83 days
Submission Type
Summary