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FDA 510(k) Application Details - K162117
Device Classification Name
Oximeter, Tissue Saturation
More FDA Info for this Device
510(K) Number
K162117
Device Name
Oximeter, Tissue Saturation
Applicant
Hamamatsu Photonics K.K.
812 Joko-cho, Higashi-ku
Hamamatsu City 431-3196 JP
Other 510(k) Applications for this Company
Contact
Susumu Suzuki
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
07/29/2016
Decision Date
10/25/2016
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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