K232888
- 510(k) number
- K232888
- Device name
- Disposable Laryngeal Electrodes
- Applicant
- Suzhou Haishen Medical Device Associates Co., Ltd. CN
- Product code
- ETN — Stimulator, Nerve
- Decision date
- 2023-12-21
- Date received
- 2023-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232888.pdf
Official FDA record: K232888
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.