FDA 510(k) Application Details - K974805

Device Classification Name	Assay, Carboxyhemoglobin   More FDA Info for this Device
510(K) Number	K974805
Device Name	Assay, Carboxyhemoglobin
Applicant	NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. SAN CARLOS, CA 94070 US Other 510(k) Applications for this Company
Contact	ESTHER KADASH Other 510(k) Applications for this Contact
Regulation Number	864.7425   More FDA Info for this Regulation Number
Classification Product Code	GHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/1997
Decision Date	03/11/1998
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