Ennova Self-adhesive Electrode— 510(k) K152648
Substantially EquivalentSuzhou Ennova Electronics Technology Co.,Ltd
FDA 510(k) clearance K152648 for Ennova Self-adhesive Electrode, Substantially Equivalent on 2016-02-18. Applicant: Suzhou Ennova Electronics Technology Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Suzhou Ennova Electronics 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
- Suzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.