Cleared Traditional

KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)

K951005 · Kenex , Ltd. · Radiology
May 1995
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K951005 is an FDA 510(k) clearance for the KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2), a Injector, Contrast Medium, Automatic (Class II — Special Controls, product code IZQ), submitted by Kenex , Ltd. (England, GB). The FDA issued a Cleared decision on May 4, 1995, 78 days after receiving the submission on February 15, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K951005 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1995
Decision Date May 04, 1995
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
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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