FDA 510(k) Application Details - K052446

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K052446
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	HOANA MEDICAL, INC. 1001 BISHOP STREET, STE 2828 AMERICAN SAVINGS BANK TOWER HONOLULU, HI 96813 US Other 510(k) Applications for this Company
Contact	MATTHEW S GLEI 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	09/07/2005
Decision Date	02/02/2006
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