Personal Kinetigraph (PKG) System Gen 2 Plus— 510(k) K211887

Substantially Equivalent

Gkc Manufacturing Pty, Ltd.

FDA 510(k) clearance K211887 for Personal Kinetigraph (PKG) System Gen 2 Plus, Substantially Equivalent on 2022-03-11. Applicant: Gkc Manufacturing Pty, Ltd..

Clearance details

Applicant: Gkc Manufacturing Pty, Ltd.
Product code: Code GYD
Advisory panel: Neurology
Date received: 2021-06-21
Decision date: 2022-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, AU

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