Anesthetic Gas Monitor Type 1304, Modified

FDA 510(k) K914295 · Bruel & Kjaer

Substantially Equivalent

510(k) numberK914295

Submission

Device name
Anesthetic Gas Monitor Type 1304, Modified
Applicant
Bruel & Kjaer
Naerum 2850, DK
Received
September 9, 1991
Decision date
April 10, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CBQ – Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1500
Specialty
Anesthesiology

Other 510(k)s with product code CBQ

510(k)DeviceApplicantDecision
K040917Philips Anesthesia Gas Monitor, Model M1026BCBQ · Special Philips Medizin Systeme Boeblingen GmbH04/29/2004SE
K994188Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5CBQ · Special Agilent Technologies, GmbH05/19/2000SE
K962648Ohmeda Model 5330 Anesthetic Agent MonitorCBQ · Traditional Ohmeda Medical01/17/1997SE
K931439Ohmeda Model 5330 Anesthetic MonitorCBQ · Traditional Ohmeda Medical10/19/1993SE
K926451Datascope Multinex IICBQ · Traditional Datascope Corp.08/25/1993SE
K923433AS/3 Anaesthesia Monitoring System Airway ModuleCBQ · Traditional Instrumentarium Corp.07/22/1993SE
K923276Capnomac Ultima Anesthesia MonitorCBQ · Traditional Datex Division Instrumentarium Corp.07/21/1993SE
K922876AS/3 Cop ModuleCBQ · Traditional Datex Division Instrumentarium Corp.07/21/1993SE
K930303Datascope Multinex Id PlusCBQ · Traditional Datascope Corp.06/16/1993SE
K911644NGM FrameCBQ · Traditional Datex Division Instrumentarium Corp.03/04/1992SE

More from Datex Division Instrumentarium Corp.

510(k)DeviceDecision
K925484Carbon Dioxide & Oxygen Monitor Type 1308CCK · Traditional 06/22/1993SE
K905198Diagnostic Ultrasound System Type 3535IYN · Traditional 08/28/1991SE
K911348Rigid EndoscopeLNH · Traditional 06/21/1991SE

Questions and answers

When was Anesthetic Gas Monitor Type 1304, Modified cleared by the FDA?

Anesthetic Gas Monitor Type 1304, Modified (K914295) received a 510(k) decision of Substantially Equivalent on April 10, 1992, 214 days after the submission was received.

What is the product code of K914295?

The FDA product code is CBQ – Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration), a Class II (moderate risk) device regulated under 21 CFR 868.1500.