FDA 510(k) Application Details - K080884

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K080884
Device Name	Electrocardiograph
Applicant	MEDTECHS, LLC 111 BEAVER DAM RUN DURHAN, NC 27703 US Other 510(k) Applications for this Company
Contact	MEGHAN ATH 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	03/31/2008
Decision Date	04/11/2008
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