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FDA 510(k)

Hemo Control (optional Add Pack Hemo Control DM)

K-Number: K200909 · 2020-06-12

ApplicantEkf-Diagnostic GmbH
Decision Date2020-06-12
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Hemo Control (optional Add Pack Hemo Control DM) is a medical device manufactured by Ekf-Diagnostic GmbH. It received FDA 510(k) clearance on 2020-06-12 under approval number K200909. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hemo Control (optional Add Pack Hemo Control DM)?

Hemo Control (optional Add Pack Hemo Control DM) is a medical device that received FDA 510(k) clearance on 2020-06-12. It is manufactured by Ekf-Diagnostic GmbH. The 510(k) number is K200909.

When was Hemo Control (optional Add Pack Hemo Control DM) approved by the FDA?

Hemo Control (optional Add Pack Hemo Control DM) received FDA 510(k) clearance on 2020-06-12, under approval number K200909.

What company makes Hemo Control (optional Add Pack Hemo Control DM)?

Hemo Control (optional Add Pack Hemo Control DM) is manufactured by Ekf-Diagnostic GmbH.

What is the FDA product code for Hemo Control (optional Add Pack Hemo Control DM)?

The FDA product code for Hemo Control (optional Add Pack Hemo Control DM) is GKR.

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Other Devices by Ekf-Diagnostic GmbH

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Related Devices (Code: GKR)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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