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FDA 510(k) Application Details - K103791
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K103791
Device Name
Electrocardiograph
Applicant
COMMWELL LTD.
RECHOV YAD HARUTZIM 4
KFAR SABA 44641 IL
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Contact
IRVING LEVY
Other 510(k) Applications for this Contact
Regulation Number
870.2340
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Classification Product Code
DPS
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More FDA Info for this Product Code
Date Received
12/27/2010
Decision Date
10/21/2011
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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