Self-adhesive Electrode— 510(k) K222252

Substantially Equivalent

Shenzhen Roundwhale Technology Co. , Ltd.

FDA 510(k) clearance K222252 for Self-adhesive Electrode, Substantially Equivalent on 2023-01-19. Applicant: Shenzhen Roundwhale Technology Co. , Ltd..

Clearance details

Applicant: Shenzhen Roundwhale Technology Co. , Ltd.
Product code: Code GXY
Advisory panel: Neurology
Date received: 2022-07-27
Decision date: 2023-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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