FDA.report

510(k) K232888

Device
Disposable Laryngeal Electrodes
Applicant
Suzhou Haishen Medical Device Associates Co., Ltd.
510(k) number
K232888
Product code
ETN
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-21
Date received
2023-09-18
Regulation
874.1820
Classification name
Stimulator, Nerve
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Leyi Dai
Address
3f, 4f (Rm. 401, 402), 5f, Bldg. 10, # 168 Majian Rd., Suzhou High-Tech Zone Suzhou CN 215000 215000

FDA Registration Numbers

Source Documents

510(k) summary PDF

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