FDA 510(k) Application Details - K043162

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K043162
Device Name	Oximeter
Applicant	CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. PO BOX 527 REHOVOT 76100 IL Other 510(k) Applications for this Company
Contact	BORIS ARADOVSKY Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2004
Decision Date	12/29/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review