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FDA 510(k) Application Details - K983575
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K983575
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
DATASCOPE CORP.
580 WINTERS AVE.
P.O. BOX 5
PARAMUS, NJ 07653 US
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Contact
RUSSELL OLSEN
Other 510(k) Applications for this Contact
Regulation Number
870.1130
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Classification Product Code
DXN
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More FDA Info for this Product Code
Date Received
10/13/1998
Decision Date
05/13/1999
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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