Source document or public record
FDA 510(k) K200909 — Hemo Control (optional Add Pack Hemo Control DM)
FDA 510(k) index record K200909. Device: Hemo Control (optional Add Pack Hemo Control DM). Applicant as listed: Ekf-Diagnostic GmbH. Decision date: 2020-06-12.
Source
"device_name": "Hemo Control (optional Add Pack Hemo Control DM)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K200909.
Device name: Hemo Control (optional Add Pack Hemo Control DM). Applicant as listed: Ekf-Diagnostic GmbH.
Decision date: 2020-06-12. Decision wording: Substantially Equivalent.
Product code: GKR. Regulation: 21 CFR 864.5620. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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