IVES EEG SOLUTIONS, LLC

Address:44 Merrimac St,Newburyport,MA,01950,US

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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

Electrode, Cutaneous (GXY) (8) Cable, Electrode (IKD) (2)

Premarket Exempt

No Yes

Clear

Ives EEG Solutions - 00850012681007 Catalog Number :

Device Description : MR Conditional Disposable EEG Cup Electrode System, 21 lead, black cup, CT compatible

Device Class :

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681014 Catalog Number : DCPE-23/B

Device Description : MR Conditional Disposable EEG Cup electrode system, 23 lead, black cup, CT compatible

Device Class :

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681021 Catalog Number :

Device Description : MR Conditional Disposable EEG Cup Electrode System, 25 lead, black cup, CT compatible

Device Class :

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681038 Catalog Number : DCPE-27/B

Device Description : MR Conditional Disposable EEG Cup Electrode System, 27 lead, black cup, CT compatible

Device Class :

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681045 Catalog Number :

Device Description : MR Conditional Disposable EEG Soft Cup electrode system, 21 lead, soft cups, CT compatible

Device Class :

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681052 Catalog Number :

Device Description : MR Conditional Disposable EEG Soft Cup electrode system, 23 lead, soft cups, CT compatible

Device Class :

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681069 Catalog Number :

Device Description : MR Conditional Disposable EEG Soft Cup Electrode System, 25 lead, soft cups, CT compatible

Device Class :

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681076 Catalog Number : DCPE-27/S

Device Description : MR Conditional Disposable EEG Soft Cup Electrode System, 27 lead, soft cup, CT compatible

Device Class :

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681083 Catalog Number :

Device Description : Ives MR Conditional Electrode System Harness, 21 lead wire harness, MR Unsafe (d Ives MR Conditional Electrode System Harness, 21 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging)

Device Class : 2

Duns Number: 015020106

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681090 Catalog Number :

Device Description : Ives MR Conditional Electrode System Harness, 23 lead wire harness, MR Unsafe (d Ives MR Conditional Electrode System Harness, 23 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging)

Device Class : 2

Duns Number: 015020106

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

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