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510(k) K871103

Device
O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P
Applicant
MATHESON GAS PRODUCTS, INC.
510(k) number
K871103
Product code
BXK  
Decision
Substantially Equivalent (SESE)
Decision date
1987-04-20
Date received
1987-03-19
Regulation
868.6400
Classification name
Gas, Calibration (specified Concentration)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DENNIS R DEPOL
Address
932 Paterson Plank Rd. East Rutheford NJ US 07073 07073

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BXK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K954804LUNG DIFFUSION MIXTURESMittler Supply, Inc.1996-01-25
K954803BLOOD GAS MIXTURESMittler Supply, Inc.1996-01-25
K954542LUNG DIFFUSION MIXTURELiquid Technology Corp.1995-12-22
K952838MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURESStandard Welders Supply Co.1995-09-19
K953934MED-TECH LUNG DIFFUSION MIXTUREMedical Technical Gases Inc..1995-09-18
K953208MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURESStandard Welders Supply Co.1995-07-20
K944998CALIBRATION GASSunox, Inc.1995-02-03
K944812CLINICAL BLOOD GAS MIXTURELaboratory & Specialty Gases, Inc.1995-02-01
K942866CLINICAL BLOOD GAS MIXTURENordan Smith Welding Supplies1994-09-01
K932874BLOOD GAS MIXTURETri-Gas, Inc.1994-01-27
K935311CLINICAL BLOOD GASAcetylene Gas Co.1993-12-22
K932520CALIBRATION GASCryodyne Technologies, Inc.1993-08-19
K924796LUNG DIFFUSION GAS MIXTUREGulf States Airgas1992-12-17
K924795BLOOD GAS MIXTUREGulf States Airgas1992-12-17
K911264CALIBRATION KITS & W Medico Teknik1991-08-02

Legacy Summary#

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FDA Review#

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