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510(k) K232385

OxiplexTS200 by Iss Medical, Inc. — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2024
Date Received
August 9, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Tissue Saturation
Device Class
Class II
Regulation Number
870.2700
Review Panel
SU
Submission Type

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