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510(k) K896396

Device
MIDA SYSTEM, MODELS 1000/1100
Applicant
MEDICAL GRAPHICS CORP.
510(k) number
K896396
Product code
DYC  
Decision
Substantially Equivalent (SESE)
Decision date
1990-01-18
Date received
1989-11-06
Regulation
870.2400
Classification name
Vectorcardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CONSTANCE G BUNDY
Address
6470 Riverview Ter. Findley MN US 55432 55432

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
K823934CARIEL F12Odam1983-12-16
K810529DIRECT WRITING VECTORCARDIOGRAPHElmed, Inc.1981-04-23

Legacy Summary#

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FDA Review#

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