FDA 510(k) Application Details - K200204

Device Classification Name	Oxyhemoglobin   More FDA Info for this Device
510(K) Number	K200204
Device Name	Oxyhemoglobin
Applicant	Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454 US Other 510(k) Applications for this Company
Contact	Rachel Gilbert Other 510(k) Applications for this Contact
Regulation Number	864.7500   More FDA Info for this Regulation Number
Classification Product Code	GGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2020
Decision Date	04/06/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review