BrainScope One

FDA UDI

Class II (US FDA UDI)

by Brainscope

Identity

Trade Name: BrainScope One FDA UDI
Generic Name: Electroencephalograph FDA UDI
Device Name: BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 00852745007222 - this is the DI for the BrainScope One Device. FDA UDI
Model / Reference: Ahead 500 FDA UDI
Description: BrainScope Part Number 99-1801-100 (SKU: BSO-2001) Contains Device Identifier (DI) 00852745007222 - this is the DI for the BrainScope One Device. FDA UDI

Identifiers

Catalog Number: BSO-2001 FDA UDI
Primary DI / UDI-DI: 00852745007239 FDA UDI
510(k) Number: K190815 FDA UDI
FDA Product Code: OLU FDA UDI
PKQ FDA UDI
PIW FDA UDI
GMDN Term: Electroencephalograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
882.1470 FDA UDI
882.1450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electroencephalograph

BrainScope One by Brainscope — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalograph.

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Natus — Natus Neurology Incorporated · Class II
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Natus — Natus Neurology Incorporated · Class II
128-channel EEG cap (L) — Megin Oy · Class II
Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
Zeto ONE Head Unit - Small — ZETO INC · Class II

Cleared under the same submission

K190815 also covers:

BrainScope One — BRAINSCOPE

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Brainscope

Sources (1)

FDA UDI 18950102-9a45-4046-b875-6fd0aaddd32a 36 fields · synced Jun 8, 2026