FDA 510(k) Application Details - K023431

Device Classification Name Flowmeter, Blood, Cardiovascular

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510(K) Number K023431
Device Name Flowmeter, Blood, Cardiovascular
Applicant CARDIOSONIX, LTD.
BEIT HAPA'AMON (BOX 124)
20 HATA'AS ST.
KFAR SABA 44425 IL
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Contact AHAVA STEIN
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Regulation Number 870.2100

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Classification Product Code DPW
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Date Received 10/15/2002
Decision Date 11/13/2002
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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