FDA 510(k) Application Details - K964406

Device Classification Name	Device, Blood Volume Measuring   More FDA Info for this Device
510(K) Number	K964406
Device Name	Device, Blood Volume Measuring
Applicant	DAXOR CORPORATION 350 FIFTH AVE., SUITE 7120 NEW YORK, NY 10118 US Other 510(k) Applications for this Company
Contact	JOSEPH FELDSCHUH Other 510(k) Applications for this Contact
Regulation Number	864.5950   More FDA Info for this Regulation Number
Classification Product Code	JWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/1996
Decision Date	09/25/1997
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