Personal Kinetigraph (PKG) System

Transducer, Tremor

GKC MANUFACTURING PTY LTD.

The following data is part of a premarket notification filed by Gkc Manufacturing Pty Ltd. with the FDA for Personal Kinetigraph (pkg) System.

Pre-market Notification Details

Device IDK161717
510k NumberK161717
Device Name:Personal Kinetigraph (PKG) System
ClassificationTransducer, Tremor
Applicant GKC MANUFACTURING PTY LTD. LEVEL 15, 440 COLLINS ST Melbourne,  AU 3000
ContactBrendan Fafiani
CorrespondentMarie A. Schroeder
QUINTILES 1801 ROCKVILLE PIKE SUITE 300 Rockville,  MD  20852
Product CodeGYD  
Subsequent Product CodeISD
Subsequent Product CodeNXQ
CFR Regulation Number882.1950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-22
Decision Date2016-09-20
Summary:summary

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