FDA 510(k) Application Details - K083534

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K083534
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	HOANA MEDICAL, INC. 828 FORT STREET MALL SUITE 620 HONOLULU, HI 96825 US Other 510(k) Applications for this Company
Contact	NANCY GERTLAR 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	11/28/2008
Decision Date	04/13/2009
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