Cleared Traditional

ulrichINJECT CT motion

K210541 · Ulrich GmbH & Co. KG · General Hospital
Aug 2021
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K210541 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 August 6, 2021, 163 days after receiving the submission on February 24, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K210541 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2021
Decision Date August 06, 2021
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
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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