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FDA 510(k) Application Details - K182868
Device Classification Name
Oximeter, Tissue Saturation
More FDA Info for this Device
510(K) Number
K182868
Device Name
Oximeter, Tissue Saturation
Applicant
Covidien llc
6135 Gunbarrel Avenue
Boulder, CO 80301 US
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Contact
Samir Ibrahim
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
MUD
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More FDA Info for this Product Code
Date Received
10/12/2018
Decision Date
01/08/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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