ActiveCare Home— 510(k) K160431

Name: FDA 510(k) clearance K160431
Creator: U.S. Food and Drug Administration
Published: 2016-07-13

Substantially Equivalent

Medical Compression Systems (Dbn) , Ltd.

FDA 510(k) clearance K160431 for ActiveCare Home, Substantially Equivalent on 2016-07-13. 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: 2016-02-16
Decision date: 2016-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Or Akiva, IL

Download summary PDF View on FDA.gov ↗

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K110159 — ACTIVECARE SFT2011-05-12
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Data sourced from openFDA. This site is unofficial and independent of the FDA.