Zekang Self-adhesive Electrode— 510(k) K150971
Substantially EquivalentJiangsu Zekang Medical Technology Co., Ltd.
FDA 510(k) clearance K150971 for Zekang Self-adhesive Electrode, Substantially Equivalent on 2015-08-25. Applicant: Jiangsu Zekang Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Jiangsu Zekang Medical Technology Co., Ltd.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuxi, CN
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