Cleared Traditional

NGM FRAME

K911644 · Datex Division Instrumentarium Corp. · Anesthesiology

Mar 1992

Decision

324d

Days

Class 2

Risk

About This 510(k) Submission

K911644 is an FDA 510(k) clearance for the NGM FRAME, 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 March 4, 1992, 324 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	K911644 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 1991
Decision Date	March 04, 1992
Days to Decision	324 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