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FDA 510(k) Application Details - K080036
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K080036
Device Name
Electrocardiograph
Applicant
DYANSYS, INC.
577 AIRPORT BLVD. SUITE 610
BURLINGAME, CA 95032 US
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Contact
SRINI NAGESHWAR
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
01/07/2008
Decision Date
01/16/2008
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
Y
Expedited Review
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