FDA 510(k) Application Details - K040178

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K040178
Device Name	Oximeter
Applicant	S.P.O. MEDICAL EQUIPMENT, LTD. 20 HATA'AS STR; STE 213 BEIT HAPAMON (BOX 124) KFAR SABA 44425 IL Other 510(k) Applications for this Company
Contact	AHAVA STEIN 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	01/26/2004
Decision Date	09/10/2004
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