Data / Medical devices / United States / BEE Systems, Inc
BEE Systems, Inc: FDA-registered device maker in Beaverton, OR, United States, 2 510(k) clearances
BEE Systems, Inc is registered with the FDA (registration 3006177498) in Beaverton, OR, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 30, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006177498
- Address
- 7724 SW Nimbus Ave Bldg 10 S, Beaverton, OR, United States, 97008
- Owner or operator
- BEE Systems, Inc (10040370)
- Roles
- Repackager or relabeler
- First device listed
- November 12, 2012
- Registered through
- 2026
- Brand names listed
- BEE Lab, Brummi, Combination Sensor, Cygnet, EEG NeuroAmp, EEG NeuroAmp II, EEG NeuroAmp II.5s, ERP Sync and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Photic, Evoked Response | GWE | 2 | Repackager or relabeler | 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 30, 2020 | K193159 | NeuroAmp II, NeuroAmp II.5s | GWQ | Substantially Equivalent | Corscience GmbH & Co. KG | accessdata.fda.gov |
| February 28, 2008 | K073557 | EEG NEUROAMP, MODEL CS10137 | HCC | Substantially Equivalent | Corscience GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Photic, Evoked Response
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Standard Polysomnograph With Electroencephalograph
- All makers of Device, Biofeedback
Updated December 30, 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.