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GWK — Conditioner, Signal, Physiological Class II

FDA Device Classification

Classification Details

Product Code
GWK
Device Class
Class II
Regulation Number
882.1845
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K060919respironicsACTICALSeptember 22, 2006
K061870respironicsVITALSENSE XHRAugust 31, 2006
K052489respironicsACTIHEARTSeptember 27, 2005
K991045mini-mitter coMINI-LOGGER SERIES 2000September 21, 1999
K905594nihon kohden americaNEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300June 28, 1991
K904328telediagnostic systemsVISTA POLYSOMNOGRAPHY COMPUTER SYSTEMJune 18, 1991
K896164astro-medASC-954 INTEGRATOR AMPLIFIERJanuary 22, 1990
K882599nicolet instrumentNICOLET BRAINLAB SYSTEMOctober 19, 1988
K872290bio-logic systemsBIO-LOGIC BANKEROctober 6, 1987
K870381grass-telefactor product groupDD-VCR-64March 25, 1987
K860914bio-feedback systemsISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONVJune 6, 1986
K843598nicolet biomedical instrumentsBRAIN FUNCTION MAPPING OPTION FOR PATHFApril 11, 1985
K841497nihon kohden americaNEUROPACK 8 MEE 4108June 7, 1984
K841110interspecNEUROTRACApril 30, 1984
K833298axonicsAUDIT V AX 135December 1, 1983
K830191neurodiagnosticsNEURO DIAGNOSTICS MODEL FCRFebruary 18, 1983
K803226bio-logic systemsEVOKED RESPONSE STIMULATORSFebruary 5, 1981
K801670neurodiagnosticsNDI-IKE EMGAugust 4, 1980
K801604nicolet biomedical instrumentsPATHFINDER ELECTRODIAGNOSTIC SYSTEMAugust 4, 1980
K781290princeton applied researchSIGNAL AVERAGER MODEL 4202September 15, 1978