510(k) K940386

KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP by Eastman Kodak Company — Product Code IXL

K940386 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP". The FDA issued a decision of Substantially Equivalent on August 17, 1994. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1994
Date Received
January 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Spot-Film
Device Class
Class II
Regulation Number
892.1670
Review Panel
RA
Submission Type