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HCC — Device, Biofeedback Class II

FDA Device Classification

Classification Details

Product Code
HCC
Device Class
Class II
Regulation Number
882.5050
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233580deepwell dtxA Breathing System (ABS)August 1, 2024
K222101graymatters healthPrismMarch 17, 2023
K180173palo alto health sciencesFreespiraAugust 23, 2018
K163448sunstar suisseGrindCare SystemSeptember 1, 2017
K151050power medical devicesPacifier Activated Lullaby (PAL®)December 22, 2015
K143507nfant labsNFANT Feeding SolutionSeptember 9, 2015
K131586palo alto health sciencesCANARY BREATHING SYSTEMDecember 10, 2013
K122879eeg softwareEEGER4 MODEL 4.3February 6, 2013
K111687myotronics-noromedEMG SYSTEMSeptember 29, 2011
K092675medotechGRINDCAREMarch 3, 2010
K073557corscience gmbh and co. kgEEG NEUROAMP, MODEL CS10137February 28, 2008
K071866kcbiomedixNTRAINER SYSTEMFebruary 1, 2008
K071661telediagnostic systemsALPHAONE BIOFEEDBACK SYSTEMSeptember 5, 2007
K041244medtronic vascularPOLYGRAM NET BIOFEEDBACK APPLICATIONAugust 12, 2004
K020399intercureRESPERATE; MODEL RR-150July 2, 2002
K010388ohmeda medicalSONDREX P.A.L. SYSTEMDecember 11, 2001
K013399myotronics-noromedMODEL MES-9000/EMG SYSTEMNovember 13, 2001
K012384bio-logic systemsEAR MUFFINSOctober 15, 2001
K012011stoeltingMODIFICATION TO A620 EEGOctober 10, 2001
K011964fasstechINSIGHT MILLENNIUM PLUSSeptember 20, 2001