K-number	K200909
Device name	Hemo Control (optional Add Pack Hemo Control DM)
Applicant	Ekf-Diagnostic GmbH
Product code	GKR
Device class	Class II
Decision date	Jun 12, 2020
Decision	Substantially Equivalent
Regulation	864.5620

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View the full FDA submission: accessdata.fda.gov

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Hemo Control (optional Add Pack Hemo Control DM)

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