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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K842051
Device Name EKG TRANSMITTER MODEL 5134
Applicant
Instromedix, Inc.
10950 SW Fifth Ave.
Beaverton,  OR  97005
Applicant Contact SEMLER
Correspondent
Instromedix, Inc.
10950 SW Fifth Ave.
Beaverton,  OR  97005
Correspondent Contact SEMLER
Regulation Number870.3610
Classification Product Code
DXY  
Date Received05/22/1984
Decision Date 03/01/1985
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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