Name: Predicase
Price: 199 USD

K-number	K230320
Device name	NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
Applicant	Medtronic Xomed, Inc.
Product code	ETN
Device class	Class II
Decision date	Oct 26, 2023
Decision	Substantially Equivalent
Regulation	874.1820

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube

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