BRAINSTREAM Disposable Deep Cup EEG Electrodes
FDA 510(k) K200540 · Conmed Corporation
510(k) numberK200540
Submission
- Device name
- BRAINSTREAM Disposable Deep Cup EEG Electrodes
- Applicant
- Conmed Corporation
Utica, NY, US - Received
- March 3, 2020
- Decision date
- June 1, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was BRAINSTREAM Disposable Deep Cup EEG Electrodes cleared by the FDA?
BRAINSTREAM Disposable Deep Cup EEG Electrodes (K200540) received a 510(k) decision of Substantially Equivalent on June 1, 2020, 90 days after the submission was received.
What is the product code of K200540?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.