FDA 510(k) Application Details - K100745

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K100745
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	HOANA MEDICAL, INC. 21031 SE 202ND STREET RENTON, WA 98058 US Other 510(k) Applications for this Company
Contact	Cindy Green Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	DRT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2010
Decision Date	04/15/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review