K-number	K220526
Device name	HD+12, HD+15
Applicant	Cardioline S.P.A
Product code	DRG
Device class	Class II
Decision date	May 15, 2023
Decision	Substantially Equivalent
Regulation	870.2910

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Source

View the full FDA submission: accessdata.fda.gov

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HD+12, HD+15

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