Personal Kinetigraph (PKG) System— 510(k) K161717

Substantially Equivalent

Gkc Manufacturing Pty, Ltd.

FDA 510(k) clearance K161717 for Personal Kinetigraph (PKG) System, Substantially Equivalent on 2016-09-20. Applicant: Gkc Manufacturing Pty, Ltd..

Clearance details

Applicant: Gkc Manufacturing Pty, Ltd.
Product code: Code GYD
Advisory panel: Neurology
Date received: 2016-06-22
Decision date: 2016-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, AU

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