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Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221512
510(k) Type
Traditional
Applicant
Vieworks Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
7/20/2022
Days to Decision
57 days
Submission Type
Summary

Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221512
510(k) Type
Traditional
Applicant
Vieworks Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
7/20/2022
Days to Decision
57 days
Submission Type
Summary