EXSURGO LIMITED

Address:Unit I / 45 William Pickering Drive,Auckland,NZ

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Biofeedback (HCC) (7)

Premarket Exempt

Yes

Clear

Axon - 09413000077094 Catalog Number : 100142

Device Description : EEG Headset - Medium

Device Class : 2

Duns Number: 594916540

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Axon - 09413000078411 Catalog Number : 100141

Device Description : EEG Headset - Small

Device Class : 2

Duns Number: 594916540

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Axon - 09413000078428 Catalog Number : 100143

Device Description : EEG Headset - Large

Device Class : 2

Duns Number: 594916540

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Axon - 09413000078435 Catalog Number : 100140

Device Description : Neurofeedback Kit - Smallincludes Axon EEG headset - Small, Tablet with Axon Neu Neurofeedback Kit - Smallincludes Axon EEG headset - Small, Tablet with Axon Neurofeedback Software Application

Device Class : 2

Duns Number: 594916540

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Axon - 09413000078442 Catalog Number : 100160

Device Description : Neurofeedback Kit - Mediumincludes Axon EEG headset - Medium, Tablet with Axon N Neurofeedback Kit - Mediumincludes Axon EEG headset - Medium, Tablet with Axon Neurofeedback Software Application

Device Class : 2

Duns Number: 594916540

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Axon - 09413000078459 Catalog Number : 100161

Device Description : EEG Biofeedback (Neurofeedback) Kit - Largeincludes Axon EEG headset - Large, Ta EEG Biofeedback (Neurofeedback) Kit - Largeincludes Axon EEG headset - Large, Tablet with Axon Neurofeedback Software Application

Device Class : 2

Duns Number: 594916540

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

Axon - 09413000078510 Catalog Number : 100321

Device Description : Neurofeedback Software Application for Android

Device Class : 2

Duns Number: 594916540

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

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