FDA 510(k) Application Details - K080602

Device Classification Name	Electrode, Electrocardiograph   More FDA Info for this Device
510(K) Number	K080602
Device Name	Electrode, Electrocardiograph
Applicant	INOVISE MEDICAL, INC. 10565 SW NIMBUS AVE. SUITE 100 PORTLAND, OR 97223 US Other 510(k) Applications for this Company
Contact	KENDRA RATHKEY Other 510(k) Applications for this Contact
Regulation Number	870.2360   More FDA Info for this Regulation Number
Classification Product Code	DRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2008
Decision Date	09/25/2008
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	N
Expedited Review