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Digital NeuroPort Biopotential Signal Processing System

FDA UDI

Class II (US FDA UDI)

by Blackrock Microsystems

Identity

Trade Name
Digital NeuroPort Biopotential Signal Processing System FDA UDI
Generic Name
Electroencephalographic signal amplifier FDA UDI
Device Name
Gemini Hub Neural Signal Processor FDA UDI
Model / Reference
12126 FDA UDI
Description
Gemini Hub Neural Signal Processor FDA UDI

Identifiers

Catalog Number
12126 FDA UDI
Primary DI / UDI-DI
00814901021442 FDA UDI
510(k) Number
K202174 FDA UDI
FDA Product Code
GWL FDA UDI
GWK FDA UDI
GMDN Term
Electroencephalographic signal amplifier FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1835 FDA UDI
882.1845 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Digital NeuroPort Biopotential Signal Processing System by Blackrock Microsystems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K202174 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Blackrock Microsystems

Sources (1)

  • FDA UDI adf86d19-8835-4865-a2ff-fff134f3c9d3 37 fields · synced Jun 8, 2026