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510(k) K960490

Device
AS/3 COMPACT AIRWAY MODULE M-CAIOV
Applicant
DATEX MEDICAL INSTRUMENTATION, INC.
510(k) number
K960490
Product code
CBS  
Decision
Substantially Equivalent (SESE)
Decision date
1996-05-03
Date received
1996-02-02
Regulation
868.1620
Classification name
Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
VINCENT RAUSCHER
Address
2 Highwood Dr. Tewksbury MA US 01876 01876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CBS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974903GAS MODULE II, MODEL 0998-00-0143Datascope Corp.1998-03-13
K953795VITALMAX 4100Pace Tech, Inc.1996-07-01
K951366RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)Riken Keiki Co., Ltd.1995-08-02
K950101RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITORMarquette Electronics, Inc.1995-03-21
K943458AS/3 AIRWAY MODULEDatex Division Instrumentarium Corp.1995-02-14
K942737POET IQ WITH FIVE AGENT CAPABILITYCriticare Systems, Inc.1995-02-09
K9323898100 ANESTHETIC AGENT MONITORBiochem International, Inc.1993-12-03
K905754CAPNOMAC ULTIMA ANESTHESIA MONITORDatex Division Instrumentarium Corp.1991-06-17
K896629NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITORNellcor, Inc.1990-02-12
K896216HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025AHewlett-Packard Co.1990-01-16
K890446ANESTHETIC GAS MONITORBruel & Kjaer Instruments, Inc.1989-08-11
K873194SPECTRAMED RESPIRATORY GAS ANALYZERDraeger Medical, Inc.1987-10-30
K863801TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATORTraverse Medical Monitors1987-01-12
K832113NORMAC ANESTHETIC AGENT MONITORDatex Division Instrumentarium Corp.1983-09-12
K810585SARAAllied Healthcare Products, Inc.1981-03-24

Legacy Summary#

summary

FDA Review#

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