Disposable Laryngeal Electrodes— 510(k) K232888
Substantially EquivalentSuzhou Haishen Medical Device Associates Co., Ltd.
FDA 510(k) clearance K232888 for Disposable Laryngeal Electrodes, Substantially Equivalent on 2023-12-21. Applicant: Suzhou Haishen Medical Device Associates Co., Ltd..
Clearance details
- Applicant
- Suzhou Haishen Medical Device Associates Co., Ltd.
- Product code
- Code ETN
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Adverse events under product code ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.