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510(k) K940426

Device
MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
Applicant
MEDTRONIC HEMOTEC, INC.
510(k) number
K940426
Product code
GKN  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-20
Date received
1994-01-31
Regulation
864.5400
Classification name
Timer, Clot, Automated
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT F BAUGH
Address
7103 S. Revere Pkwy. Englewood CO US 80112 80112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GKN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K953870ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTSMedtronic Vascular1995-10-31
K913320MIL CM-II COAGULATION MACHINEMedical Innovations Corp.1992-06-16

Legacy Summary#

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FDA Review#

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