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Alphenix, INFX-8000C/B, V8.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181804
510(k) Type
Traditional
Applicant
Canon Medical Systems Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
8/2/2018
Days to Decision
27 days
Submission Type
Summary

Alphenix, INFX-8000C/B, V8.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181804
510(k) Type
Traditional
Applicant
Canon Medical Systems Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
8/2/2018
Days to Decision
27 days
Submission Type
Summary