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510(k) K791959

Device
POST EXTRA SYSTOLIC POSTENTLATOR
Applicant
MEDRAD, INC.
510(k) number
K791959
Product code
IXO  
Decision
Substantially Equivalent (SESE)
Decision date
1980-01-09
Date received
1979-10-01
Regulation
892.1970
Classification name
Synchronizer, Ecg / Respirator, Radiographic
Medical specialty
Radiology
Review panel
Radiology
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 IXO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K854976RMI RESPIRATORY GATING SYSTEM MODEL 301Radiation Measurements, Inc.1986-05-07
K811587SIEMENS ANGIOTRONSiemens Corp.1981-07-10
K810588SYNCHRONIZER #208Brattle Instrument Corp.1981-04-10

Legacy Summary#

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FDA Review#

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