FDA 510(k) Application Details - K993104

Device Classification Name	Oximeter To Measure Hemoglobin   More FDA Info for this Device
510(K) Number	K993104
Device Name	Oximeter To Measure Hemoglobin
Applicant	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454-9141 US Other 510(k) Applications for this Company
Contact	PAUL W MAC DONALD 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	09/16/1999
Decision Date	12/02/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review