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510(k) K854976

Device
RMI RESPIRATORY GATING SYSTEM MODEL 301
Applicant
RADIATION MEASUREMENTS, INC.
510(k) number
K854976
Product code
IXO  
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-07
Date received
1985-12-12
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#

Contact
MICHELE J WOLFF
Address
P.O. Box 327 7617 Donna Dr. Middleton WI US 53562 53562

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
K811587SIEMENS ANGIOTRONSiemens Corp.1981-07-10
K810588SYNCHRONIZER #208Brattle Instrument Corp.1981-04-10
K791959POST EXTRA SYSTOLIC POSTENTLATORMedrad, Inc.1980-01-09

Legacy Summary#

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FDA Review#

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