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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K070550
Device Name AUSCO ES-3100
Applicant
Koratek Company, Ltd.
1733 Canton Ln.
Marietta,  GA  30062
Applicant Contact PAUL SUMNER
Correspondent
Koratek Company, Ltd.
1733 Canton Ln.
Marietta,  GA  30062
Correspondent Contact PAUL SUMNER
Regulation Number870.1875
Classification Product Code
DQD  
Date Received02/27/2007
Decision Date 11/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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