Cleared Traditional

RADIOGRAPHIC FILM PROCESSOR M-30CR &

K841431 · The Allen Products Co. · Radiology
Jul 1984
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K841431 is an FDA 510(k) clearance for the RADIOGRAPHIC FILM PROCESSOR M-30CR &, a Processor, Cine Film (Class II — Special Controls, product code IXX), submitted by The Allen Products Co. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984, 91 days after receiving the submission on April 6, 1984. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1900.

Submission Details

510(k) Number K841431 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1984
Decision Date July 06, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code IXX — Processor, Cine Film
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1900