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FDA 510(k) Application Details - K020587
Device Classification Name
Probe, Thermodilution
More FDA Info for this Device
510(K) Number
K020587
Device Name
Probe, Thermodilution
Applicant
PULSION MEDICAL SYSTEMS AG
100 MAIN ST.
STE. 120
CONCORD, MA 01742 US
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Contact
JAMES M DELANEY
Other 510(k) Applications for this Contact
Regulation Number
870.1915
More FDA Info for this Regulation Number
Classification Product Code
KRB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/22/2002
Decision Date
05/23/2002
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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