Disposable Laryngeal Electrodes
K-Number: K232888 · 2023-12-21
Decision Date2023-12-21
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Disposable Laryngeal Electrodes is a medical device manufactured by Suzhou Haishen Medical Device Associates Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under approval number K232888. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposable Laryngeal Electrodes?
Disposable Laryngeal Electrodes is a medical device that received FDA 510(k) clearance on 2023-12-21. It is manufactured by Suzhou Haishen Medical Device Associates Co., Ltd.. The 510(k) number is K232888.
When was Disposable Laryngeal Electrodes approved by the FDA?
Disposable Laryngeal Electrodes received FDA 510(k) clearance on 2023-12-21, under approval number K232888.
What company makes Disposable Laryngeal Electrodes?
Disposable Laryngeal Electrodes is manufactured by Suzhou Haishen Medical Device Associates Co., Ltd..
What is the FDA product code for Disposable Laryngeal Electrodes?
The FDA product code for Disposable Laryngeal Electrodes is ETN.
Related Clinical Trials
Other Devices by Suzhou Haishen Medical Device Associates Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.