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Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223694
510(k) Type
Traditional
Applicant
Duearity AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
6/30/2023
Days to Decision
203 days
Submission Type
Summary

Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223694
510(k) Type
Traditional
Applicant
Duearity AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
6/30/2023
Days to Decision
203 days
Submission Type
Summary