Cleared Special

E-Z EM PERCUPUMP 2001 CT INJECTOR

K011160 · E-Z-Em, Inc. · Radiology
May 2001
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K011160 is an FDA 510(k) clearance for the E-Z EM PERCUPUMP 2001 CT INJECTOR, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on May 16, 2001, 30 days after receiving the submission on April 16, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K011160 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2001
Decision Date May 16, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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