Self-adhesive Electrode— 510(k) K222453
Substantially EquivalentGuangdong Comytens Medical Technology Co., Ltd.
FDA 510(k) clearance K222453 for Self-adhesive Electrode, Substantially Equivalent on 2022-11-04. Applicant: Guangdong Comytens Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangdong Comytens 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
- Shenzhen, CN
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