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FDA 510(k) Application Details - K091054
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
More FDA Info for this Device
510(K) Number
K091054
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
ET MEDICAL DEVICES SPA
6, VIA DE ZINIS
CAVARENO(TN) 38011 IT
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Contact
LUIGO BUCCHI
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
MWJ
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More FDA Info for this Product Code
Date Received
04/13/2009
Decision Date
07/27/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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