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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
K140086
510(k) Type
Traditional
Applicant
GKC MANUFACTURING PTY LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/22/2014
Days to Decision
220 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
K140086
510(k) Type
Traditional
Applicant
GKC MANUFACTURING PTY LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/22/2014
Days to Decision
220 days
Submission Type
Summary