Name: Predicase
Price: 199 USD

K-number	K232581
Device name	Medical Disposable Sterile Needle Electrode
Applicant	Suzhou Haishen Medical Device Associates Co., Ltd.
Product code	GXZ
Device class	Class II
Decision date	Dec 4, 2023
Decision	Substantially Equivalent
Regulation	882.1350

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Source

View the full FDA submission: accessdata.fda.gov

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Medical Disposable Sterile Needle Electrode

Everything you need for a 510(k) submission. Nothing you don't.