Cleared Traditional

MODEL 556 MONITOR

K905856 · Ge Medical Systems Information Technologies · Cardiovascular
Jan 1991
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K905856 is an FDA 510(k) clearance for the MODEL 556 MONITOR, a Recorder, Paper Chart (Class I — General Controls, product code DSF), submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on January 11, 1991, 88 days after receiving the submission on October 15, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2810.

Submission Details

510(k) Number K905856 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1990
Decision Date January 11, 1991
Days to Decision 88 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