Disposable Non-invasive EEG Sensor
FDA 510(k) K220448 · Shenzhen Med-Link Electronics Tech Co., Ltd.
510(k) numberK220448
Submission
- Device name
- Disposable Non-invasive EEG Sensor
- Applicant
- Shenzhen Med-Link Electronics Tech Co., Ltd.
Shenzhen, CN - Received
- February 16, 2022
- Decision date
- January 19, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K182667 | Med-link Temperature ProbesFLL · Traditional | 06/18/2019SE |
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Questions and answers
When was Disposable Non-invasive EEG Sensor cleared by the FDA?
Disposable Non-invasive EEG Sensor (K220448) received a 510(k) decision of Substantially Equivalent on January 19, 2023, 337 days after the submission was received.
What is the product code of K220448?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.