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510(k) K211887

Device
Personal Kinetigraph (PKG) System Gen 2 Plus
Applicant
GKC Manufacturing Pty Ltd
510(k) number
K211887
Product code
GYD  
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-11
Date received
2021-06-21
Regulation
882.1950
Classification name
Transducer, Tremor
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jim Quackenbush
Address
Level 9, 31 Queen St. Melbourne AU 3000 3000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GYD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250153Neu PlatformNeuhealth Digital , Ltd.2025-04-25
K221772NeuroRPMNew Touch Digital, Inc.2023-03-17
K220820Parky AppH2o Bilisim Yazilim2022-11-17
K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.2022-06-10
K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.2016-09-20
K140086PERSONAL KINETIGRAPH (PKG) SYSTEMGkc Manufacturing Pty, Ltd.2014-08-22
K063872KINESIACleveland Medical Devices, Inc.2007-04-06
K010270TREMOROMETERFlexable Systems, Inc.2001-07-25
K011429MODEL 100 ACTIVITY MONITORTelecom Medical, Inc.2001-07-13
K971318MM-1 MOVEMENT MONITORAxon Instruments, Inc.1997-07-28
K782036TREMOR MONITORColumbus Instruments Intl. Corp.1979-01-23

Legacy Summary#

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FDA Review#

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