Disposable EEG Cable

Electrode, Cutaneous

Shenzhen Changke Connect Electronics Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Changke Connect Electronics Co., Ltd. with the FDA for Disposable Eeg Cable.

Pre-market Notification Details

Device IDK213884
510k NumberK213884
Device Name:Disposable EEG Cable
ClassificationElectrode, Cutaneous
Applicant Shenzhen Changke Connect Electronics Co., Ltd. A1-2nd And A2 4th Floor Of Factory Building, No.87 Of Hengping Road, Baoan Community, Yuanshan Shenzhen,  CN 518115
ContactYahui Zhou
CorrespondentKevin Wang
Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen,  CN 518067
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-13
Decision Date2022-05-06


Device IdentifiersubmissionNumberSupplement
16973874210176 K213884 000
16973874210169 K213884 000
16973874210152 K213884 000
16973874210145 K213884 000
06973874210179 K213884 000
06973874210162 K213884 000
06973874210155 K213884 000
06973874210148 K213884 000

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