Medical Disposable Sterile Needle Electrode— 510(k) K232581

Name: FDA 510(k) clearance K232581
Creator: U.S. Food and Drug Administration
Published: 2023-12-04

Substantially Equivalent

Suzhou Haishen Medical Device Associates Co., Ltd.

FDA 510(k) clearance K232581 for Medical Disposable Sterile Needle Electrode, Substantially Equivalent on 2023-12-04. Applicant: Suzhou Haishen Medical Device Associates Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzhou Haishen Medical Device Associates Co., Ltd.
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 2023-08-25
Decision date: 2023-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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