SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System— 510(k) K211937

Name: FDA 510(k) clearance K211937
Creator: U.S. Food and Drug Administration
Published: 2021-11-18

Substantially Equivalent

Jiangsu Synecoun Medical Technology Co., Ltd.

FDA 510(k) clearance K211937 for SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System, Substantially Equivalent on 2021-11-18. Applicant: Jiangsu Synecoun Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jiangsu Synecoun Medical Technology Co., Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2021-06-22
Decision date: 2021-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taizhou, CN

Download summary PDF View on FDA.gov ↗

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