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FDA 510(k) Application Details - K102767
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K102767
Device Name
Electrocardiograph
Applicant
BIONET CO., LTD.
5405 ALTON PARKWAY,
SUITE A530
IRVINE, CA 92604 US
Other 510(k) Applications for this Company
Contact
MARC GOODMAN
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/2010
Decision Date
06/03/2011
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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