FDA 510(k) Application Details - K013725

Device Classification Name Stethoscope, Electronic

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510(K) Number K013725
Device Name Stethoscope, Electronic
Applicant MEDITRON AS
103 NOLEN LN.
CHAPEL HILL, NC 27516 US
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Contact CHARLES H KYPER
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 11/09/2001
Decision Date 01/30/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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