ACTIVECARE SFT— 510(k) K110159

Name: FDA 510(k) clearance K110159
Creator: U.S. Food and Drug Administration
Published: 2011-05-12

Substantially Equivalent

Medical Compression Systems (Dbn) , Ltd.

FDA 510(k) clearance K110159 for ACTIVECARE SFT, Substantially Equivalent on 2011-05-12. Applicant: Medical Compression Systems (Dbn) , Ltd.. Device class: 2.

Clearance details

Applicant: Medical Compression Systems (Dbn) , Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2011-01-19
Decision date: 2011-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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