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ISEN-Goggles with Data Viewer

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163270
510(k) Type
Traditional
Applicant
ISENT TECH & TRADING COMPANY,LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/25/2017
Days to Decision
308 days
Submission Type
Summary

ISEN-Goggles with Data Viewer

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163270
510(k) Type
Traditional
Applicant
ISENT TECH & TRADING COMPANY,LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/25/2017
Days to Decision
308 days
Submission Type
Summary