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FDA 510(k) Application Details - K023759
Device Classification Name
Stethoscope, Electronic
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510(K) Number
K023759
Device Name
Stethoscope, Electronic
Applicant
SONOMEDICA
8230 LEESBURG PIKE
SUITE 500
VIENNA, VA 22182 US
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Contact
SAILOR MOHLER
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Regulation Number
870.1875
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Classification Product Code
DQD
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More FDA Info for this Product Code
Date Received
11/08/2002
Decision Date
05/06/2003
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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