FDA 510(k) Application Details - K150235

Device Classification Name Amplifier And Signal Conditioner, Transducer Signal

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510(K) Number K150235
Device Name Amplifier And Signal Conditioner, Transducer Signal
Applicant BOSTON SCIENTIFIC CORPORATION
55 TECHNOLOGY DRIVE
LOWELL, MA 01851 US
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Contact MAYLIN TRUESDELL
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Regulation Number 870.2060

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Classification Product Code DRQ
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Date Received 02/02/2015
Decision Date 04/22/2015
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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