Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004964738

FEI Number

3004964738

Entity Name

ADVANCED BRAIN MONITORING, INC.

City/State/Country

CARLSBAD, CA, US

Establishment Address

2237 FARADAY AVE STE 100, CARLSBAD, CA 92008, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ADVANCED BRAIN MONITORING, INC. (Owner Number: 9064303)

Owner / Operator Contact Address

2237 FARADAY AVENUE, SUITE 100, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152040

PMA Number

N/A

All Registered Proprietary Names

Sleep Profiler Software Night Shift Therapy X10 System X24 System X4 Hardware Sleep Profiler Software Positional Sleep Assessment System (PoSAS) Software Sleep Profiler Software X4 Apnea Guard X8 System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2016-03-15
MYB	Pillow, Cervical (For Mild Sleep Apnea)	Dental	Class 2	872.5570	2014-06-09
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2013-12-06
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2013-12-06
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2012-07-18
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2013-03-25
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2018-03-12
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2018-03-12
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2014-06-09
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2014-06-09
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2012-07-18
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2015-11-06
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2015-11-06

Official Correspondent

DANIEL LEVENDOWSKI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ADVANCED BRAIN MONITORING, 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
K100160	Sleep Specialists, LLC	ZZOMA POSITIONAL SLEEPER MODEL 001	2010-05-11
K180608	Nightbalance BV	Lunoa System	2018-06-05
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

Similar Registrations

Registration Number	Establishment Name	Location
9612330	NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)	OAKVILLE Ontario, CA
1063925	NEUROTRONICS, LLC	Alachua, FL, US
3026753386	ONERA B.V.	Eindhoven Noord-Brabant, NL
3007389703	NOX MEDICAL	Reykjavik, IS
3011120183	Plexus Electronica S. de R.L. de C.V..	Zapopan Jalisco, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004964738. Last updated year: 2026. Please use registration number 3004964738 when referencing this establishment in official correspondence.