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510(k) K790213

Device
GENERATOR, R-WAVE
Applicant
AMR CO.
510(k) number
K790213
Product code
IYY  
Decision
Substantially Equivalent (SESE)
Decision date
1979-03-22
Date received
1979-01-30
Regulation
892.1410
Classification name
Synchronizer, Electrocardiograph, Nuclear
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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IYY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K853737VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)Capintec, Inc.1986-02-13
K780510NUCLEAR STETHOSCOPEBios, Inc.1978-04-18

Legacy Summary#

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FDA Review#

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