FDA 510(k) Application Details - K093976

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K093976
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	PROTEUS BIOMEDICAL, INC. 2600 BRIDGE PARKWAY SUITE 101 REDWOOD CITY, CA 94065 US Other 510(k) Applications for this Company
Contact	GREGORY MOON Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/24/2009
Decision Date	03/25/2010
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