AS/3 Airway Module

Q: When was AS/3 Airway Module cleared by the FDA?

AS/3 Airway Module (K943458) received a 510(k) decision of Substantially Equivalent on February 14, 1995, 211 days after the submission was received.

Q: What is the product code of K943458?

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.

FDA 510(k) K943458 · Datex Division Instrumentarium Corp.

Substantially Equivalent

510(k) numberK943458

Submission

Device name: AS/3 Airway Module
Applicant: Datex Division Instrumentarium Corp.
Helsinki, FI
Received: July 18, 1994
Decision date: February 14, 1995
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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)	Device	Applicant	Decision
K974903	Gas Module II, Model 0998-00-0143CBS · Traditional	Datascope Corp.	03/13/1998SE
K953795	Vitalmax 4100CBS · Traditional	Pace Tech, Inc.	07/01/1996SE
K960490	AS/3 Compact Airway Module M-CaiovCBS · Traditional	Datex Medical Instrumentation, Inc.	05/03/1996SE
K951366	Riken Gas Indicator (3 Models, 1806H, 1802D, IF-18)CBS · Traditional	Riken Keiki Co., Ltd.	08/02/1995SE
K950101	Rams (Random Access Mass Spectrometer) M-200 Respiratory Gas MonitorCBS · Traditional	Marquette Electronics, Inc.	03/21/1995SE
K942737	Poet Iq with Five Agent CapabilityCBS · Traditional	Criticare Systems, Inc.	02/09/1995SE
K932389	8100 Anesthetic Agent MonitorCBS · Traditional	Biochem International, Inc.	12/03/1993SE
K905754	Capnomac Ultima Anesthesia MonitorCBS · Traditional	Datex Division Instrumentarium Corp.	06/17/1991SE
K896629	Nellcor Model N-2500 Anesthesia Safety MonitorCBS · Traditional	Nellcor, Inc.	02/12/1990SE
K896216	Hewlett Packard Anesthetic Gas Analyzer M1025ACBS · Traditional	Hewlett-Packard Co.	01/16/1990SE

More from Hewlett-Packard Co.

510(k)	Device	Decision
K953175	AS/3 Estpr ModuleMLD · Traditional	02/06/1997SE
K961247	AS/3 Light MonitorDPS · Traditional	10/23/1996SE
K945234	AS/3 Memory Module, M0MEMBSZ · Traditional	01/27/1995SE
K933156	Datex AS/3 Patient MonitorDPS · Traditional	12/30/1994SE
K933285	Datex AS/3 TM Anaesthesia MonitorBSZ · Traditional	11/14/1994SE
K943456	AS/3 Nellcor Compatible Saturation Moodule, M-NsatDQA · Traditional	10/17/1994SE
K923172	Anaesthesia Record KeeperBSZ · Traditional	08/09/1994SE
K935477	AS/3(TM) Anesthesia Monitor Syst Interface BoardCCK · Traditional	08/01/1994SE
K943457	AS/3 Pressure Temperature Module, M-PtDSK · Traditional	07/27/1994SE
K933284	AS/3 TM NetworkCCK · Traditional	07/11/1994SE

Questions and answers

When was AS/3 Airway Module cleared by the FDA?

AS/3 Airway Module (K943458) received a 510(k) decision of Substantially Equivalent on February 14, 1995, 211 days after the submission was received.

What is the product code of K943458?

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.