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Auxilock GFS Mini, GFS II Large, and GFS Ultimate

Page Type
Cleared 510(K)
510(k) Number
K213018
510(k) Type
Traditional
Applicant
Auxein Medical Private Limited
Country
India
FDA Decision
Substantially Equivalent
Decision Date
11/18/2022
Days to Decision
424 days
Submission Type
Summary

Auxilock GFS Mini, GFS II Large, and GFS Ultimate

Page Type
Cleared 510(K)
510(k) Number
K213018
510(k) Type
Traditional
Applicant
Auxein Medical Private Limited
Country
India
FDA Decision
Substantially Equivalent
Decision Date
11/18/2022
Days to Decision
424 days
Submission Type
Summary