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FDA 510(k) Application Details - K955045
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K955045
Device Name
Electrocardiograph
Applicant
INVIVO RESEARCH, INC.
12601 RESEARCH PKWY.
ORLANDO, FL 32826 US
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Contact
FRANCIS X CASEY
Other 510(k) Applications for this Contact
Regulation Number
870.2340
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Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/03/1995
Decision Date
07/11/1996
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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