BRAINMATTERZ, INC

FDA Device Registration & Listing · McKinney, TX, US · Registration 3038274470

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
3038274470
FEI Number
3038274470
Entity Name
BRAINMATTERZ, INC
City/State/Country
McKinney, TX, US
Establishment Address
6710 Virginia Pkwy Ste 215, Pmb 12, McKinney, TX 75071, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BrainMatterZ, Inc (Owner Number: 10093071)
Owner / Operator Contact Address
7535 W Grand Pkwy S, Richmond, TX 77407, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223676
PMA Number
N/A

All Registered Proprietary Names

BrainMatterZ HST Patch BrainMatterZ System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2025-03-26
GWL Amplifier, Physiological Signal Neurology Class 2 882.1835 2025-03-26

Official Correspondent

Roni Diaz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K082968 Apneicare, LLC APNEICARE CONNECTION CENTER/INTERNET ANALYSIS 2009-01-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2022 NOX MEDICAL Keldnaholt Reykjavik Iceland 2
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038274470. Last updated year: 2026. Please use registration number 3038274470 when referencing this establishment in official correspondence.
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