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FDA 510(k) Application Details - K971840
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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510(K) Number
K971840
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant
INVIVO RESEARCH, INC.
12601 RESEARCH PKWY.
ORLANDO, FL 32826 US
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Contact
FRANCIS X CASEY
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Regulation Number
870.1025
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Classification Product Code
MHX
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More FDA Info for this Product Code
Date Received
05/19/1997
Decision Date
03/04/1998
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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