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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 K013725
Device Name MEDITRON II THESTERTHOSCOPE SYSTEM
Applicant
Meditron AS
103 Nolen Ln.
Chapel Hill,  NC  27516
Applicant Contact CHARLES H KYPER
Correspondent
Meditron AS
103 Nolen Ln.
Chapel Hill,  NC  27516
Correspondent Contact CHARLES H KYPER
Regulation Number870.1875
Classification Product Code
DQD  
Date Received11/09/2001
Decision Date 01/30/2002
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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