Cleared Traditional

AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE

K923433 · Instrumentarium Corp. · Anesthesiology

Jul 1993

Decision

374d

Days

Class 2

Risk

About This 510(k) Submission

K923433 is an FDA 510(k) clearance for the AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE, a Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (Class II — Special Controls, product code CBQ), submitted by Instrumentarium Corp. (Finland, FI). The FDA issued a Cleared decision on July 22, 1993, 374 days after receiving the submission on July 13, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1500.

Submission Details

510(k) Number	K923433 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 1992
Decision Date	July 22, 1993
Days to Decision	374 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement

Device Classification

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