Cleared Abbreviated

EMPOWERMR INJECTOR SYSTEM, MODEL 9730

K062449 · E-Z-Em, Inc. · Cardiovascular
Apr 2007
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K062449 is an FDA 510(k) clearance for the EMPOWERMR INJECTOR SYSTEM, MODEL 9730, a Injector, Contrast Medium, Automatic (Class II — Special Controls, product code IZQ), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on April 13, 2007, 234 days after receiving the submission on August 22, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K062449 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2006
Decision Date April 13, 2007
Days to Decision 234 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code IZQ — Injector, Contrast Medium, Automatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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