Name: Predicase
Price: 199 USD

K-number	K213687
Device name	32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
Applicant	Neocoil, LLC
Product code	MOS
Device class	Class II
Decision date	Mar 11, 2022
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch

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