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FDA 510(k) Application Details - K160173
Device Classification Name
Echocardiograph
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510(K) Number
K160173
Device Name
Echocardiograph
Applicant
Boston Scientific Corporation
47215 Lakeview Boulevard
Fremont, CA 94538 US
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Contact
Eric Elliott
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Regulation Number
870.2330
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Classification Product Code
DXK
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More FDA Info for this Product Code
Date Received
01/27/2016
Decision Date
02/26/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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