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510(k) K790334

Device
DRAGER ORM
Applicant
DRAEGER MEDICAL, INC.
510(k) number
K790334
Product code
BYR  
Decision
Substantially Equivalent (SESE)
Decision date
1979-03-07
Date received
1979-02-16
Regulation
868.2875
Classification name
Transducer, Gas Pressure, Differential
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K896718BICORE VARIFLEX(R) FLOW TRANSDUCERBicore Monitoring Systems1990-02-22
K801880MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANSMedical Measurements, Inc.1980-08-14

Legacy Summary#

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FDA Review#

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