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Personal Kinetigraph (PKG) System Gen 2 Plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211887
510(k) Type
Traditional
Applicant
GKC Manufacturing Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
3/11/2022
Days to Decision
263 days
Submission Type
Summary

Personal Kinetigraph (PKG) System Gen 2 Plus

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211887
510(k) Type
Traditional
Applicant
GKC Manufacturing Pty Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
3/11/2022
Days to Decision
263 days
Submission Type
Summary