FDA 510(k) Application Details - K050014

Device Classification Name	Oximeter To Measure Hemoglobin   More FDA Info for this Device
510(K) Number	K050014
Device Name	Oximeter To Measure Hemoglobin
Applicant	NIR DIAGNOSTICS, INC. 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA A SINCLAIR Other 510(k) Applications for this Contact
Regulation Number	864.7500   More FDA Info for this Regulation Number
Classification Product Code	GLY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2005
Decision Date	05/05/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review