Anesthetic Gas Monitor

FDA 510(k) K890446 · Bruel & Kjaer Instruments, Inc.

Substantially Equivalent

510(k) numberK890446

Submission

Device name
Anesthetic Gas Monitor
Applicant
Bruel & Kjaer Instruments, Inc.
Marlborough, MA, US
Received
January 27, 1989
Decision date
August 11, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CBS – Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1620
Specialty
Anesthesiology

Other 510(k)s with product code CBS

510(k)DeviceApplicantDecision
K974903Gas Module II, Model 0998-00-0143CBS · Traditional Datascope Corp.03/13/1998SE
K953795Vitalmax 4100CBS · Traditional Pace Tech, Inc.07/01/1996SE
K960490AS/3 Compact Airway Module M-CaiovCBS · Traditional Datex Medical Instrumentation, Inc.05/03/1996SE
K951366Riken Gas Indicator (3 Models, 1806H, 1802D, IF-18)CBS · Traditional Riken Keiki Co., Ltd.08/02/1995SE
K950101Rams (Random Access Mass Spectrometer) M-200 Respiratory Gas MonitorCBS · Traditional Marquette Electronics, Inc.03/21/1995SE
K943458AS/3 Airway ModuleCBS · Traditional Datex Division Instrumentarium Corp.02/14/1995SE
K942737Poet Iq with Five Agent CapabilityCBS · Traditional Criticare Systems, Inc.02/09/1995SE
K9323898100 Anesthetic Agent MonitorCBS · Traditional Biochem International, Inc.12/03/1993SE
K905754Capnomac Ultima Anesthesia MonitorCBS · Traditional Datex Division Instrumentarium Corp.06/17/1991SE
K896629Nellcor Model N-2500 Anesthesia Safety MonitorCBS · Traditional Nellcor, Inc.02/12/1990SE

More from Nellcor, Inc.

510(k)DeviceDecision
K901881Vibrometry SystemLNN · Traditional 05/31/1991SE
K827409Real Time Ultrasound Scanner 1849 · Traditional 07/09/1982SE
K827380Scanner Type 1846 · Traditional 07/09/1982SE

Questions and answers

When was Anesthetic Gas Monitor cleared by the FDA?

Anesthetic Gas Monitor (K890446) received a 510(k) decision of Substantially Equivalent on August 11, 1989, 196 days after the submission was received.

What is the product code of K890446?

The FDA product code is CBS – Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.), a Class II (moderate risk) device regulated under 21 CFR 868.1620.