Venera 508 Deep Vein Thrombosis (DVT) Prevention System— 510(k) K180389

Name: FDA 510(k) clearance K180389
Creator: U.S. Food and Drug Administration
Published: 2018-06-29

Substantially Equivalent

Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

FDA 510(k) clearance K180389 for Venera 508 Deep Vein Thrombosis (DVT) Prevention System, Substantially Equivalent on 2018-06-29. Applicant: Suzhou Minhua Medical Apparatus Supplies Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2018-02-13
Decision date: 2018-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.