BLACKROCK NEUROMED, LLC

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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

Amplifier, Physiological Signal (GWL) (8) Conditioner, Signal, Physiological (GWK) (8) Full-Montage Standard Electroencephalograph (GWQ) (8) Standard Polysomnograph With Electroencephalograph (OLV) (8) Electrode, Cortical (GYC) (1)

Premarket Exempt

Clear

CERVELLO 32 - 00850154007000 Catalog Number : 7511

Device Description : Cervello 32 LTM / Ambulatory Headbox, needs Jack Box - Bluetooth Model

Device Class : 2

Duns Number: 069799474

Premarket Exempt : No

Product Code : GWK, OLV, GWQ, GWL

Prescription Use : Yes

Device Count : 1

CERVELLO 64 - 00850154007017 Catalog Number : 7523

Device Description : Cervello 64 LTM / Ambulatory Headbox, needs Jack Box - Bluetooth Model

Device Class : 2

Duns Number: 069799474

Premarket Exempt : No

Product Code : GWQ, GWL, GWK, OLV

Prescription Use : Yes

Device Count : 1

CERVELLO 32 W - 00850154007024 Catalog Number : NM-0261

Device Description : Cervello 32 LTM / Ambulatory Headbox, needs Jack Box - WiFi Model

Device Class : 2

Duns Number: 069799474

Premarket Exempt : No

Product Code : GWL, GWQ, OLV, GWK

Prescription Use : Yes

Device Count : 1

CERVELLO 64 W - 00850154007031 Catalog Number : NM-0262

Device Description : Cervello 64 LTM / Ambulatory Headbox, needs Jack Box - WiFi Model

Device Class : 2

Duns Number: 069799474

Premarket Exempt : No

Product Code : GWL, GWQ, OLV, GWK

Prescription Use : Yes

Device Count : 1

JB CERVELLO 32 - 00850154007048 Catalog Number : 7512

Device Description : JackBox with 32 Common Reference Inputs, 21 arranged as Head Shape, 8 to be swit

Device Class : 2

Duns Number: 069799474

Premarket Exempt : No

Product Code : GWL, GWQ, OLV, GWK

Prescription Use : Yes

Device Count : 1

JB CERVELLO 64 - 00850154007055 Catalog Number : 7524

Device Description : JackBox with 64 Common Reference Inputs, with 6 of them to be switched to Bipola

Device Class : 2

Duns Number: 069799474

Premarket Exempt : No

Product Code : GWL, GWQ, OLV, GWK

Prescription Use : Yes

Device Count : 1

CERVELLO STIM - 00850154007062 Catalog Number : NM-0353

Device Description : Cortical / Intracranial Stimulator to be combined with CERVELLO 64 Series Amplifiers

Device Class : 2

Duns Number: 069799474

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

MORPHEUS - 00850154007079 Catalog Number : NM-0354

Device Description : Micromed MORPHEUS Amplifer for HOME LTM.

Device Class : 2

Duns Number: 069799474

Premarket Exempt : No

Product Code : GWL, GWQ, OLV, GWK

Prescription Use : Yes

Device Count : 1

CERVELLO SOFTWARE - 00850154007086 Catalog Number : RS-0003

Device Description : Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all

Device Class : 2

Duns Number: 069799474

Premarket Exempt : No

Product Code : GWL, GWQ, OLV, GWK

Prescription Use : Yes

Device Count : 1

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