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Blackrock NeuroPort Biopotential Signal Processing System

FDA UDI

Class II (US FDA UDI)

by Blackrock Microsystems

Identity

Trade Name
Blackrock NeuroPort Biopotential Signal Processing System FDA UDI
Generic Name
Electroencephalographic electronic-signal simulator FDA UDI
Device Name
Digital Neural Signal Simulator FDA UDI
Model / Reference
8282 FDA UDI
Description
Digital Neural Signal Simulator FDA UDI

Identifiers

Catalog Number
8282 FDA UDI
Primary DI / UDI-DI
00814901020209 FDA UDI
510(k) Number
K090957 FDA UDI
FDA Product Code
GWL FDA UDI
GMDN Term
Electroencephalographic electronic-signal simulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1835 FDA UDI
Commercial Distribution
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

No

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

Category: Electroencephalographic electronic-signal simulator

Blackrock 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

K090957 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 3e7bd9a0-6406-4ae5-b3ca-e265ea7bcbbd 36 fields · synced Jun 8, 2026