K-number	K210036
Device name	Carnation Ambulatory Monitor (CAM)
Applicant	Bardy Diagnostics, Inc.
Product code	DSH
Device class	Class II
Decision date	Feb 5, 2021
Decision	Substantially Equivalent
Regulation	870.2800

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Source

View the full FDA submission: accessdata.fda.gov

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Carnation Ambulatory Monitor (CAM)

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