Cleared Traditional

NGM GAS MODULE

K911647 · Datex Division Instrumentarium Corp. · Anesthesiology

Sep 1991

Decision

157d

Days

Class 2

Risk

About This 510(k) Submission

K911647 is an FDA 510(k) clearance for the NGM GAS MODULE, a Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (Class II — Special Controls, product code CBQ), submitted by Datex Division Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on September 19, 1991, 157 days after receiving the submission on April 15, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1500.

Submission Details

510(k) Number	K911647 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 1991
Decision Date	September 19, 1991
Days to Decision	157 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—

Device Classification

Product Code	CBQ — Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.1500