Cleared Special

MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5

K994188 · Agilent Technologies, GmbH · Anesthesiology

May 2000

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K994188 is an FDA 510(k) clearance for the MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5, a Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (Class II — Special Controls, product code CBQ), submitted by Agilent Technologies, GmbH (Boeblingen, DE). The FDA issued a Cleared decision on May 19, 2000, 158 days after receiving the submission on December 13, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1500.

Submission Details

510(k) Number	K994188 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 1999
Decision Date	May 19, 2000
Days to Decision	158 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

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