FDA 510(k) Application Details - K001852

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K001852
Device Name	Computer, Diagnostic, Programmable
Applicant	ITAMAR MEDICAL (C.M.) 1997 LTD. P.O.B. 454 GINOT SHOMRON 44853 44853 IL Other 510(k) Applications for this Company
Contact	AHAVA STEIN Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2000
Decision Date	02/21/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review