Cleared Traditional

AS/3 COP MODULE

K922876 · Datex Division Instrumentarium Corp. · Anesthesiology

Jul 1993

Decision

401d

Days

Class 2

Risk

About This 510(k) Submission

K922876 is an FDA 510(k) clearance for the AS/3 COP MODULE, a Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (Class II — Special Controls, product code CBQ), submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on July 21, 1993, 401 days after receiving the submission on June 15, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1500.

Submission Details

510(k) Number	K922876 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 1992
Decision Date	July 21, 1993
Days to Decision	401 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