Sequential Compression System (SCD600)— 510(k) K250190

Name: FDA 510(k) clearance K250190
Creator: U.S. Food and Drug Administration
Published: 2025-12-08

Substantially Equivalent

Shenzhen Comen Medical Instruments Co.,Ltd

FDA 510(k) clearance K250190 for Sequential Compression System (SCD600), Substantially Equivalent on 2025-12-08. Applicant: Shenzhen Comen Medical Instruments Co.,Ltd. Device class: 2.

Clearance details

Applicant: Shenzhen Comen Medical Instruments Co.,Ltd
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2025-01-23
Decision date: 2025-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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