Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006177498

FEI Number

3006177498

Entity Name

BEE Systems, Inc

City/State/Country

Beaverton, OR, US

Establishment Address

7724 SW Nimbus Ave, Bldg 10 S, Beaverton, OR 97008, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

BEE Systems, Inc (Owner Number: 10040370)

Owner / Operator Contact Address

7724 SW Nimbus Ave, Bldg 10 S, Beaverton, OR 97008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193159

PMA Number

N/A

All Registered Proprietary Names

EEG NeuroAmp II ERPrec Brummi NeuroAmp x39 EEG NeuroAmp II.5s Combination Sensor NeuroAmp x23 BEE Lab ERP Sync

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2021-03-11
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2021-03-11
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2021-03-11
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2021-03-11
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2021-03-11

Official Correspondent

Bernhard Wandernoth

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BEE Systems, 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
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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.

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1650946	COMPUMEDICS USA, INC.	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006177498. Last updated year: 2026. Please use registration number 3006177498 when referencing this establishment in official correspondence.