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FDA 510(k) Application Details - K970879
Device Classification Name
System, Ecg Analysis
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510(K) Number
K970879
Device Name
System, Ecg Analysis
Applicant
SCHILLER AMERICA, INC.
3002 DOW AVE., #138
TUSTIN, CA 92780 US
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MARKUS MARITZ
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Regulation Number
000.0000
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Classification Product Code
LOS
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More FDA Info for this Product Code
Date Received
03/10/1997
Decision Date
06/25/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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