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510(k) K810529

Device
DIRECT WRITING VECTORCARDIOGRAPH
Applicant
ELMED, INC.
510(k) number
K810529
Product code
DYC  
Decision
Substantially Equivalent (SESE)
Decision date
1981-04-23
Date received
1981-02-26
Regulation
870.2400
Classification name
Vectorcardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
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 DYC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023414MIDA ALGORITHM REV. BOrtivus AB2003-12-05
K896396MIDA SYSTEM, MODELS 1000/1100Medical Graphics Corp.1990-01-18
K823934CARIEL F12Odam1983-12-16

Legacy Summary#

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FDA Review#

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