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510(k) K220117

ARC Intensive Care Information System (ARC System) by Ordinatrum Solutions — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2023
Date Received
January 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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