FLOWTRON UNIVERSAL, MODEL AC600— 510(k) K010744

Name: FDA 510(k) clearance K010744
Creator: U.S. Food and Drug Administration
Published: 2002-03-26

Substantially Equivalent

Huntleigh Healthcare, Inc.

FDA 510(k) clearance K010744 for FLOWTRON UNIVERSAL, MODEL AC600, Substantially Equivalent on 2002-03-26. Applicant: Huntleigh Healthcare, Inc.. Device class: 2.

Clearance details

Applicant: Huntleigh Healthcare, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2001-03-13
Decision date: 2002-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eatontown, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K010744

K-number listed on FDA's recall record

Z-0615-2013 — Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.Class II·Terminated·Arjo, Inc. dba ArjoHuntleigh·20121210

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010744.

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