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PENTAX Video Upper G.I. Scope EG34-i10

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180292
510(k) Type
Traditional
Applicant
PENTAX Medical of America, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/12/2018
Days to Decision
253 days
Submission Type
Summary

PENTAX Video Upper G.I. Scope EG34-i10

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180292
510(k) Type
Traditional
Applicant
PENTAX Medical of America, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/12/2018
Days to Decision
253 days
Submission Type
Summary