Cleared Traditional

NGM ESTP MODULE

K911646 · Datex Division Instrumentarium Corp. · Cardiovascular
Feb 1992
Decision
312d
Days
Class 2
Risk

About This 510(k) Submission

K911646 is an FDA 510(k) clearance for the NGM ESTP MODULE, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Datex Division Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on February 21, 1992, 312 days after receiving the submission on April 15, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K911646 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1991
Decision Date February 21, 1992
Days to Decision 312 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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