PERSONAL KINETIGRAPH (PKG) SYSTEM— 510(k) K140086

Substantially Equivalent

Gkc Manufacturing Pty, Ltd.

FDA 510(k) clearance K140086 for PERSONAL KINETIGRAPH (PKG) SYSTEM, Substantially Equivalent on 2014-08-22. Applicant: Gkc Manufacturing Pty, Ltd..

Clearance details

Applicant: Gkc Manufacturing Pty, Ltd.
Product code: Code GYD
Advisory panel: Neurology
Date received: 2014-01-14
Decision date: 2014-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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