FDA 510(k) Application Details - K062149

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K062149
Device Name	Oximeter
Applicant	INTERNATIONAL BUSINESS STRATEGIES 1667A MARSH HABOR LN. MOUNT PLEASANT, SC 29464 US Other 510(k) Applications for this Company
Contact	BILL ROETTGER 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	07/27/2006
Decision Date	05/31/2007
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