Cleared Traditional

GRI LASERGRAPH(TM) ECG PAPER

K902586 · Gri Medical Products, Inc. · Cardiovascular
Jun 1990
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K902586 is an FDA 510(k) clearance for the GRI LASERGRAPH(TM) ECG PAPER, a Recorder, Paper Chart (Class I — General Controls, product code DSF), submitted by Gri Medical Products, Inc. (Norwalk, US). The FDA issued a Cleared decision on June 22, 1990, 10 days after receiving the submission on June 12, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2810.

Submission Details

510(k) Number K902586 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1990
Decision Date June 22, 1990
Days to Decision 10 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