Cleared Traditional

CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR

K903104 · Datex Division Instrumentarium Corp. · Anesthesiology

Jan 1991

Decision

194d

Days

Class 2

Risk

About This 510(k) Submission

K903104 is an FDA 510(k) clearance for the CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR, 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 January 23, 1991, 194 days after receiving the submission on July 13, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1500.

Submission Details

510(k) Number	K903104 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 1990
Decision Date	January 23, 1991
Days to Decision	194 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