FDA 510(k) Application Details - K062338

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K062338
Device Name	Oximeter
Applicant	PHD MEDICAL 4 INNOVATION DRIVE DUNDAS, ON L9H 7P3 CA Other 510(k) Applications for this Company
Contact	NANCY RUTH 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	08/10/2006
Decision Date	10/25/2006
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