FDA 510(k) Application Details - K060898

Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function

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510(K) Number K060898
Device Name Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant PULSION MEDICAL SYSTEMS AG
P.O. BOX 99033
RALEIGH, NC 27624 US
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Contact Jamie Sulley
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Regulation Number 870.1435

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Classification Product Code DXG
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Date Received 04/03/2006
Decision Date 07/25/2006
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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