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510(k) K843843

Device
HE TEST
Applicant
ERICH JAEGER, INC.
510(k) number
K843843
Product code
BSE  
Decision
Substantially Equivalent (SESE)
Decision date
1984-12-04
Date received
1984-10-01
Regulation
868.1640
Classification name
Analyzer, Gas, Helium, Gaseous-phase
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
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 BSE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K903939PANDA HELIUM GAS ANALYZERMedical Associated Services, Inc.1991-01-03
K841858SPIROLOOPDatamed, Inc.1984-07-11

Legacy Summary#

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FDA Review#

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