Data / Medical devices / United States / Advanced Brain Monitoring, Inc.

Advanced Brain Monitoring, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 10 510(k) clearances

Name: Advanced Brain Monitoring, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Advanced Brain Monitoring, Inc. is registered with the FDA (registration 3004964738) in Carlsbad, CA, United States. It lists 7 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 9, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004964738
Address: 2237 Faraday Ave Ste 100, Carlsbad, CA, United States, 92008
Owner or operator: ADVANCED BRAIN MONITORING, INC. (9064303)
Roles: Manufacturer
First device listed: July 18, 2012
Registered through: 2026
Brand names listed: Apnea Guard, Night Shift Therapy, Positional Sleep Assessment System (PoSAS) Software, Sleep Profiler Software, X10 System, X24 System, X4, X4 Hardware and more

Devices it lists

Device	Product code	Class	Role	Source
Automatic Event Detection Software For Polysomnograph With Electroencephalograph	OLZ	2	Manufacturer	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Pillow, Cervical (For Mild Sleep Apnea)	MYB	2	Manufacturer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Manufacturer	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Manufacturer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 9, 2018	K172799	Positional Sleep Assessment System (PoSAS) software	MNR	Substantially Equivalent	Advanced Brain Monitoring	accessdata.fda.gov
March 14, 2016	K153412	Sleep Profiler	OLZ	Substantially Equivalent	Advanced Brain Monitoring, Inc.	accessdata.fda.gov
October 30, 2015	K152040	X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)	OMC	Substantially Equivalent	Advanced Brain Monitoring, Inc.	accessdata.fda.gov
May 29, 2014	K140190	NIGHT SHIFT	MYB	Substantially Equivalent	Advanced Brain Monitoring, Inc.	accessdata.fda.gov
November 27, 2013	K131383	X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE	GWQ	Substantially Equivalent	Advanced Brain Monitoring, Inc.	accessdata.fda.gov
April 17, 2013	K130007	SLEEP PROFILER	OLZ	Substantially Equivalent	Advanced Brain Monitoring, Inc.	accessdata.fda.gov
January 31, 2013	K130013	X4 SYSTEM	OMC	Substantially Equivalent	Advanced Brain Monitoring, Inc.	accessdata.fda.gov
September 19, 2012	K120450	SLEEP PROFILER	OLZ	Substantially Equivalent	Advanced Brain Monitoring, Inc.	accessdata.fda.gov
June 20, 2012	K120447	X4	OMC	Substantially Equivalent	Advanced Brain Monitoring, Inc.	accessdata.fda.gov
July 22, 2011	K111110	APNEA GUARD	LRK	Substantially Equivalent	Advanced Brain Monitoring, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 9, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.