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FDA 510(k) Application Details - K974492
Device Classification Name
Monitor, St Segment With Alarm
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510(K) Number
K974492
Device Name
Monitor, St Segment With Alarm
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact
JACQUELINE E M. EMERY
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Regulation Number
870.1025
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Classification Product Code
MLD
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More FDA Info for this Product Code
Date Received
11/28/1997
Decision Date
02/26/1998
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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