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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
Bioelectrical signal analysis software FDA UDI
Device Name
NeuroPort Central Suite FDA UDI
Model / Reference
7.0.2 FDA UDI
Description
NeuroPort Central Suite FDA UDI

Identifiers

Catalog Number
RS-0101 FDA UDI
Primary DI / UDI-DI
00814901020292 FDA UDI
510(k) Number
K090957 FDA UDI
FDA Product Code
GWL FDA UDI
GMDN Term
Bioelectrical signal analysis software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1835 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

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

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 7f495c87-4587-4148-8ae9-332d511d6098 37 fields · synced May 30, 2026