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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Defibrillator
510(k) Number K904159
Device Name DEFIBRILLATOR ANALYZER MODEL QED-5
Applicant
Bio-Tek Instruments, Inc.
Hihgland Park
Box 998
Winooski,  VT  05404
Applicant Contact MICHAEL N SEVIGNY
Correspondent
Bio-Tek Instruments, Inc.
Hihgland Park
Box 998
Winooski,  VT  05404
Correspondent Contact MICHAEL N SEVIGNY
Regulation Number870.5325
Classification Product Code
DRL  
Date Received09/11/1990
Decision Date 03/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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