Cleared Traditional

COLORADO COLOR IMAGING RECORDER

K902230 · Honeywell, Inc. · Cardiovascular
Jun 1990
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K902230 is an FDA 510(k) clearance for the COLORADO COLOR IMAGING RECORDER, a Recorder, Paper Chart (Class I — General Controls, product code DSF), submitted by Honeywell, Inc. (Denver, US). The FDA issued a Cleared decision on June 19, 1990, 33 days after receiving the submission on May 17, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2810.

Submission Details

510(k) Number K902230 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 1990
Decision Date June 19, 1990
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DSF — Recorder, Paper Chart
Device Class Class I — General Controls
CFR Regulation 21 CFR 870.2810