510(k) K213884
K213884 is an FDA 510(k) premarket notification submitted by Shenzhen Changke Connect Electronics Co., Ltd. for the device "Disposable EEG cable". The FDA issued a decision of Substantially Equivalent on May 6, 2022. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Shenzhen Changke Connect Electronics Co., Ltd. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2022
- Date Received
- Dec 13, 2021
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type
- 510(k)