FDA 510(k) Application Details - K011865

Device Classification Name Computer, Blood-Pressure

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510(K) Number K011865
Device Name Computer, Blood-Pressure
Applicant ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON, MA 01803 US
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Contact PAUL DIAS
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Regulation Number 870.1110

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Classification Product Code DSK
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Date Received 06/14/2001
Decision Date 07/31/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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