K232581
- 510(k) number
- K232581
- Device name
- Medical Disposable Sterile Needle Electrode
- Applicant
- Suzhou Haishen Medical Device Associates Co., Ltd. CN
- Product code
- GXZ — Electrode, Needle
- Decision date
- 2023-12-04
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232581.pdf
Official FDA record: K232581
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.