Cleared Traditional

GABRIEL MEDICAL CLS THERMAL RECORDER

K901385 · Gabriel Medical, Inc. · Cardiovascular
May 1990
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K901385 is an FDA 510(k) clearance for the GABRIEL MEDICAL CLS THERMAL RECORDER, a Recorder, Paper Chart (Class I — General Controls, product code DSF), submitted by Gabriel Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on May 9, 1990, 44 days after receiving the submission on March 26, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2810.

Submission Details

510(k) Number K901385 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1990
Decision Date May 09, 1990
Days to Decision 44 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