K-number	K160840
Device name	ECG100+, ECG200+
Applicant	Cardioline S.P.A
Product code	DPS
Device class	Class II
Decision date	Aug 12, 2016
Decision	Substantially Equivalent
Regulation	870.2340

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Source

View the full FDA submission: accessdata.fda.gov

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ECG100+, ECG200+

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