FDA 510(k) Application Details - K102433

Device Classification Name Flowmeter, Blood, Cardiovascular

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510(K) Number K102433
Device Name Flowmeter, Blood, Cardiovascular
Applicant MOOR INSTRUMENTS LTD.
MILLWEY
AXMINSTER, DEVON EX135HU GB
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Contact XIABING HUANG
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Regulation Number 870.2100

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Classification Product Code DPW
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Date Received 08/26/2010
Decision Date 11/18/2010
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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