FDA 510(k) Application Details - K043380

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K043380
Device Name	Electrocardiograph
Applicant	MONEBO TECHNOLOGIES, INC. 1800 BARTON CREEK BLVD AUSTIN, TX 78735 US Other 510(k) Applications for this Company
Contact	DALE J MISCZYNSKI 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	12/08/2004
Decision Date	04/26/2005
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