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FDA 510(k) Application Details - K163472
Device Classification Name
Oximeter, Tissue Saturation
More FDA Info for this Device
510(K) Number
K163472
Device Name
Oximeter, Tissue Saturation
Applicant
VIOPTIX, INC.
39655 EUREKA DRIVE
NEWARK, CA 94560 US
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Contact
MARK LONSINGER
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
MUD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/2016
Decision Date
11/16/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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