Disposable EEG cable
FDA 510(k) K213884 · Shenzhen Changke Connect Electronics Co., Ltd.
510(k) numberK213884
Submission
- Device name
- Disposable EEG cable
- Applicant
- Shenzhen Changke Connect Electronics Co., Ltd.
Shenzhen, CN - Received
- December 13, 2021
- Decision date
- May 6, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| K191428 | ECG CableDSA · Traditional | 11/27/2019SE |
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Questions and answers
When was Disposable EEG cable cleared by the FDA?
Disposable EEG cable (K213884) received a 510(k) decision of Substantially Equivalent on May 6, 2022, 144 days after the submission was received.
What is the product code of K213884?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.