Data / Medical devices / United States / Neurovirtual Usa, Inc.

Neurovirtual Usa, Inc.: FDA-registered device maker in Fort Lauderdale, FL, United States, 9 510(k) clearances

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

Neurovirtual Usa, Inc. is registered with the FDA (registration 3006125362) in Fort Lauderdale, FL, United States. It lists 8 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 14, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006125362
Address: 3303 W Commercial Blvd Suite 100, Fort Lauderdale, FL, United States, 33309
Owner or operator: NEUROVIRTUAL USA, INC. (9091724)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: November 8, 2011
Registered through: 2026
Brand names listed: BWMINI BASICS, BWMINI COMPASS HST, BWMINI EEG, BWMINI HST, BWMINI PSG, Maxxi Cannula, Maxxi Capno Sensor, Maxxi Flow Sensor and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Complaint file establishment, Repackager or relabeler	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
December 14, 2020	K201495	Maxxi Flow Sensor	MNR	Substantially Equivalent	Neurovirtual USA, Inc.	accessdata.fda.gov
May 22, 2020	K192488	CO2 Sidestream Module	CCK	Substantially Equivalent	Beijing Kingst Commercial & Trade Co., Ltd.	accessdata.fda.gov
April 24, 2020	K191492	Maxxi Position Sensor	GWQ	Substantially Equivalent	Neurovirtual USA, Inc.	accessdata.fda.gov
January 16, 2020	K191095	Maxxi Snore Sensor	MNR	Substantially Equivalent	Neurovirtual USA, Inc.	accessdata.fda.gov
June 24, 2019	K171304	Maxxi Rip Sensor	MNR	Substantially Equivalent	Neurovirtual USA, Inc.	accessdata.fda.gov
April 11, 2017	K163547	MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96	GXY	Substantially Equivalent	Neurovirtual USA, Inc.	accessdata.fda.gov
February 3, 2015	K131335	BWMINI EEG, BWMINIHST, BWMINI PSG	GWQ	Substantially Equivalent	Neurovirtual USA, Inc.	accessdata.fda.gov
October 28, 2011	K112107	BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS	GWQ	Substantially Equivalent	Neurovirtual USA, Inc.	accessdata.fda.gov
June 10, 2009	K083010	SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR	DQA	Substantially Equivalent	Shenzhen Med-Link Electronics Tech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 14, 2020. 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.