ActiveCare+SFT; ActiveCare+SFT HomeCare, ActiveCare+DTx; ActiveCare+DTx HomeCare— 510(k) K151377

Name: FDA 510(k) clearance K151377
Creator: U.S. Food and Drug Administration
Published: 2015-07-16

Substantially Equivalent

Medical Compression System (Dbn) , Ltd.

FDA 510(k) clearance K151377 for ActiveCare+SFT; ActiveCare+SFT HomeCare, ActiveCare+DTx; ActiveCare+DTx HomeCare, Substantially Equivalent on 2015-07-16. Applicant: Medical Compression System (Dbn) , Ltd.. Device class: 2.

Clearance details

Device name as filed: ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare
Applicant: Medical Compression System (Dbn) , Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2015-05-22
Decision date: 2015-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Or-Akiva, 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.