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510(k) K902021

Device
RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR
Applicant
ALBION INSTRUMENTS
510(k) number
K902021
Product code
CBQ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-10-09
Date received
1990-05-03
Regulation
868.1500
Classification name
Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HIBDON, MS
Address
4745 Wiley Post Way,650 Plz. 6 Salt Lake City UT US 84116 84116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CBQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040917PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026BPhilips Medizin Systeme Boeblingen GmbH2004-04-29
K994188MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5Agilent Technologies, GmbH2000-05-19
K962648OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOROhmeda Medical1997-01-17
K931439OHMEDA MODEL 5330 ANESTHETIC MONITOROhmeda Medical1993-10-19
K926451DATASCOPE MULTINEX IIDatascope Corp.1993-08-25
K923433AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULEInstrumentarium Corp.1993-07-22
K923276CAPNOMAC ULTIMA ANESTHESIA MONITORDatex Division Instrumentarium Corp.1993-07-21
K922876AS/3 COP MODULEDatex Division Instrumentarium Corp.1993-07-21
K930303DATASCOPE MULTINEX ID PLUSDatascope Corp.1993-06-16
K914295ANESTHETIC GAS MONITOR TYPE 1304, MODIFIEDBruel & Kjaer1992-04-10
K911644NGM FRAMEDatex Division Instrumentarium Corp.1992-03-04
K911647NGM GAS MODULEDatex Division Instrumentarium Corp.1991-09-19
K903104CAPNOMAC ULTIMA (TM) ANESTHESIA MONITORDatex Division Instrumentarium Corp.1991-01-23
K892854ANESTHETIC AGENT MONITORCriticare Systems, Inc.1989-10-13
K892646BIOCHEM 8100 ANESTHETIC AGENT MONITORBiochem International, Inc.1989-08-31

Legacy Summary#

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FDA Review#

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