Cleared Traditional

KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP

K940386 · Eastman Kodak Company · Radiology
Aug 1994
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K940386 is an FDA 510(k) clearance for the KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP, a Device, Spot-film (Class II — Special Controls, product code IXL), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on August 17, 1994, 203 days after receiving the submission on January 26, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1670.

Submission Details

510(k) Number K940386 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1994
Decision Date August 17, 1994
Days to Decision 203 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXL — Device, Spot-film
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1670