FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable EEG cable
K Number: K213884
·
Decision May 6, 2022
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
8
Review Days
144
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Basic Information
- Device Name
- Disposable EEG cable
- K Number
- K213884
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Changke Connect Electronics Co., Ltd.
- Date Received
- December 13, 2021
- Decision Date
- May 6, 2022
- Product Code
- GXY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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Other Clearances by Shenzhen Changke Connect Electronics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K193625 | Disposable Temperature Probe | Jul 24, 2020 | Substantially Equivalent |
| K200026 | Disposable ECG Cable | May 12, 2020 | Substantially Equivalent |
| K193629 | Disposable NIBP Cuff | Mar 25, 2020 | Substantially Equivalent |
| K200069 | Disposable SpO2 Sensor | Mar 13, 2020 | Substantially Equivalent |
| K191428 | ECG Cable | Nov 27, 2019 | Substantially Equivalent |
| K191420 | Reusable SpO2 Sensor | Oct 11, 2019 | Substantially Equivalent |
| K191253 | Reusable NIBP Cuff | Sep 17, 2019 | Substantially Equivalent |