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FDA 510(k)

Disposable Laryngeal Electrodes

K-Number: K232888 · 2023-12-21

ApplicantSuzhou Haishen Medical Device Associates Co., Ltd.
Decision Date2023-12-21
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Disposable Laryngeal Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Haishen Medical Device Associates Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) 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. The listed applicant is Suzhou Haishen Medical Device Associates Co., Ltd.. The 510(k) number is K232888.

When did Disposable Laryngeal Electrodes receive FDA 510(k) clearance?

Disposable Laryngeal Electrodes received FDA 510(k) clearance on 2023-12-21, under 510(k) number K232888.

Who is the listed applicant for Disposable Laryngeal Electrodes?

The FDA 510(k) record lists Suzhou Haishen Medical Device Associates Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Laryngeal Electrodes?

The FDA product code for Disposable Laryngeal Electrodes is ETN.

Other records listing Suzhou Haishen Medical Device Associates Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232581Medical Disposable Sterile Needle Electrode

Related Devices (Code: ETN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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