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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Timer, Clot, Automated
510(k) Number K940426
Device Name MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
Applicant
Medtronic Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact ROBERT F BAUGH
Correspondent
Medtronic Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact ROBERT F BAUGH
Regulation Number864.5400
Classification Product Code
GKN  
Date Received01/31/1994
Decision Date 09/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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