Last synced on 17 May 2024 at 11:06 pm

Personal Kinetigraph (PKG) System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161717
510(k) Type
Traditional
Applicant
GKC MANUFACTURING PTY LTD.
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
9/20/2016
Days to Decision
90 days
Submission Type
Summary

Personal Kinetigraph (PKG) System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161717
510(k) Type
Traditional
Applicant
GKC MANUFACTURING PTY LTD.
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
9/20/2016
Days to Decision
90 days
Submission Type
Summary