FDA 510(k) Application Details - K180186

Device Classification Name	Oxyhemoglobin   More FDA Info for this Device
510(K) Number	K180186
Device Name	Oxyhemoglobin
Applicant	Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 US Other 510(k) Applications for this Company
Contact	Adam Heroux 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	01/23/2018
Decision Date	08/23/2018
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