510(k) K232888

Disposable Laryngeal Electrodes by Suzhou Haishen Medical Device Associates Co., Ltd. — Product Code ETN

K232888 is an FDA 510(k) premarket notification submitted by Suzhou Haishen Medical Device Associates Co., Ltd. for the device "Disposable Laryngeal Electrodes". The FDA issued a decision of Substantially Equivalent on December 21, 2023. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Suzhou Haishen Medical Device Associates Co., Ltd. has at least 1 other 510(k) clearance on record.