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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
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