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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Lead Switching, Electrocardiograph
510(k) Number K851627
Device Name KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR
Applicant
Eaton Medical Group
P.O. Box 276
Eaton,  MI 
Applicant Contact PAUL P KLUWE
Correspondent
Eaton Medical Group
P.O. Box 276
Eaton,  MI 
Correspondent Contact PAUL P KLUWE
Regulation Number870.2350
Classification Product Code
DRW  
Date Received04/18/1985
Decision Date 11/08/1985
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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