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FDA 510(k) Application Details - K001762
Device Classification Name
Computer, Diagnostic, Pre-Programmed, Single-Function
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510(K) Number
K001762
Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Applicant
PULSION MEDICAL SYSTEMS, INC.
20462-A CHARTWELL CENTER DR.
PO BOX 2637
CORNELIUS, NC 28031 US
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ULF BORG
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Regulation Number
870.1435
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Classification Product Code
DXG
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Date Received
06/09/2000
Decision Date
06/13/2000
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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