K-number	K243157
Device name	AtriCure cryoICE BOX (ACM)
Applicant	AtriCure, Inc.
Product code	GXH
Device class	Class II
Decision date	Oct 29, 2024
Decision	Substantially Equivalent
Regulation	882.4250

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Source

View the full FDA submission: accessdata.fda.gov

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AtriCure cryoICE BOX (ACM)

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