BRAINSCOPE

FDA Device Registration & Listing · Rockville, MD, US · Registration 3008660657

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008660657
FEI Number
3008660657
Entity Name
BRAINSCOPE
City/State/Country
Rockville, MD, US
Establishment Address
7648 Standish Place, Rockville, MD 20855, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BrainScope Company, Inc. (Owner Number: 10039715)
Owner / Operator Contact Address
7648 Standish Place, Rockville, MD 20855, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181179
PMA Number
N/A

All Registered Proprietary Names

BrainScope One Ahead® 300 BrainScope One (Model: Ahead 500) BrainScope One

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLU Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2017-02-15
PKQ Computerized Cognitive Assessment Aid Neurology Class 2 882.1470 2017-02-15
PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Neurology Class 2 882.1450 2017-02-15
OLU Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2019-12-17
PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Neurology Class 2 882.1450 2019-12-17
PKQ Computerized Cognitive Assessment Aid Neurology Class 2 882.1470 2019-12-17
OLU Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2018-12-11
PIW Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Neurology Class 2 882.1450 2018-12-11
PKQ Computerized Cognitive Assessment Aid Neurology Class 2 882.1470 2018-12-11

Official Correspondent

Leslie Prichep

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BrainScope Company, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008660657. Last updated year: 2026. Please use registration number 3008660657 when referencing this establishment in official correspondence.
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