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510(k) K901548

Device
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
Applicant
SHILEY, INC.
510(k) number
K901548
Product code
CCC  
Decision
Substantially Equivalent (SESE)
Decision date
1991-01-14
Date received
1990-04-03
Regulation
868.1150
Classification name
Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ABATI, PHD
Address
17600 Gillette Ave. P.O. Box 19503 Irvine CA US 92714 92714

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CCC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K071165ISCALERT SENSOR SYSTEMAlertis Medical AS2007-11-07
K983198TRENDCARE CALIBRATOR MODEL SCU 7007Diametrics Medical, Ltd.1999-11-23
K972314PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEMDiametrics Medical, Ltd.1997-12-19
K953893PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEMBiomedical Sensors, Inc.1997-11-04
K961790POINT-OF-CARE BLOOD GAS MONITOR SYSTEMOptical Sensors, Inc.1997-04-09
K963935OLYMPUS CRITICAL CARE MONITORING SYSTEMOptical Sensors, Inc.1997-01-23
K951094POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEMOptical Sensors, Inc.1996-01-16
K940188PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEMBiomedical Sensors, Ltd.1995-11-13
K931185SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTEOptical Sensors, Inc.1993-10-21
K891013MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORINGMedtronic Vascular1989-08-02
K870911INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALYAmerican Bentley1987-05-29
K780185OXYGEN ANALYZER 110Siemens Corp.1978-03-17
K771722SENSOMATBiochem International, Inc.1977-09-26
K760088ANALYZER, SENTORR BLOOD GASOhio Medical Products1976-08-06

Legacy Summary#

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FDA Review#

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