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 - 00850012681106 Catalog Number :

Device Description : Ives MR Conditional Electrode System Harness, 25 lead wire harness, MR Unsafe (d Ives MR Conditional Electrode System Harness, 25 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 - 00850012681113 Catalog Number :

Device Description : Ives MR Conditional Electrode System Harness, 27 lead wire harness, MR Unsafe (d Ives MR Conditional Electrode System Harness, 27 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 - 00850012681182 Catalog Number : DCPEX-21/B

Device Description : Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 21 leads, black c Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 21 leads, black cup, with disposable 21 lead harness

Device Class : 2

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681199 Catalog Number : DCPEX-23/B

Device Description : Disposable Conductive Plastic Electrodes, MR/CT Compatible, 23 leads, black cup, Disposable Conductive Plastic Electrodes, MR/CT Compatible, 23 leads, black cup, with disposable 23 lead harness

Device Class : 2

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681205 Catalog Number : DCPEX-25/B

Device Description : Disposable Conductive Electrode Set, MR/CT Compatible, 25 leads, black cup, with Disposable Conductive Electrode Set, MR/CT Compatible, 25 leads, black cup, with disposable 25 lead harness

Device Class : 2

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681212 Catalog Number : DCPEX-27/B

Device Description : Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 27 leads, black c Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 27 leads, black cup, with disposable 27 lead harness

Device Class : 2

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681229 Catalog Number : DCPEX-21/S

Device Description : Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 21 leads, soft cu Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 21 leads, soft cup, with disposable 21 lead harness

Device Class : 2

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681236 Catalog Number : DCPEX-23/S

Device Description : Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 23 leads, soft cu Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 23 leads, soft cup, with disposable 23 lead harness

Device Class : 2

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681243 Catalog Number : DCPEX-25/S

Device Description : Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 25 leads, soft cu Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 25 leads, soft cup, with disposable 25 lead harness

Device Class : 2

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Ives EEG Solutions - 00850012681250 Catalog Number : DCPEX-27/S

Device Description : Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 27 leads, soft cu Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 27 leads, soft cup, with disposable 27 lead harness

Device Class : 2

Duns Number: 015020106

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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