BLACKROCK MICROSYSTEMS, LLC

Address:630 S Komas Dr Ste 200,Salt Lake City,UT,84108,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, Cortical (GYC) (8) Amplifier, Physiological Signal (GWL) (2)

Premarket Exempt

Clear

Blackrock NeuroPort Biopotential Signal Processing System - 00814901020308 Catalog Number : RS-0101

Device Description : NeuroPort Central Suite

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GWL

Prescription Use : No

Device Count : 1

Blackrock NeuroPort Biopotential Signal Processing System - 00814901020315 Catalog Number : RS-0115

Device Description : NeuroPort Central Suite

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GWL

Prescription Use : No

Device Count : 1

XactStrip - 00814901020339 Catalog Number : 027683

Device Description : XactStrip, 6 Contact, Platinum, 1x6, 5mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020353 Catalog Number : 027684

Device Description : XactStrip, 8 Contact, Platinum, 1x8, 5mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020377 Catalog Number : 027685

Device Description : XactStrip, 10 Contact, Platinum, 1x10, 5mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020391 Catalog Number : 027682

Device Description : XactStrip, 4 Contact, Platinum, 1x4, 5mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020407 Catalog Number : 028939

Device Description : XactStrip, 4 Contact, Platinum, Reinforcement, 1x4, 5mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020421 Catalog Number : 028940

Device Description : XactStrip, 6 Contact, Platinum, Reinforcement, 1x6, 5mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020445 Catalog Number : 028941

Device Description : XactStrip, 8 Contact, Platinum, Reinforcement, 1x8, 5mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

XactStrip - 00814901020469 Catalog Number : 028942

Device Description : XactStrip, 10 Contact, Platinum, Reinforcement, 1x10, 5mm Spacing

Device Class : 2

Duns Number: 827132015

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

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