Cleared Traditional

ulrichINJECT CT motion

K171392 · Ulrich GmbH & Co. KG · Cardiovascular
Nov 2017
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K171392 is an FDA 510(k) clearance for the ulrichINJECT CT motion, a Injector, Contrast Medium, Automatic (Class II — Special Controls, product code IZQ), submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on November 9, 2017, 182 days after receiving the submission on May 11, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K171392 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2017
Decision Date November 09, 2017
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

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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