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FDA 510(k)

ARC Intensive Care Information System (ARC System)

K-Number: K220117 · 2023-06-06

ApplicantOrdinatrum Solutions
Decision Date2023-06-06
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARC Intensive Care Information System (ARC System) is a medical device manufactured by Ordinatrum Solutions. It received FDA 510(k) clearance on 2023-06-06 under approval number K220117. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARC Intensive Care Information System (ARC System)?

ARC Intensive Care Information System (ARC System) is a medical device that received FDA 510(k) clearance on 2023-06-06. It is manufactured by Ordinatrum Solutions. The 510(k) number is K220117.

When was ARC Intensive Care Information System (ARC System) approved by the FDA?

ARC Intensive Care Information System (ARC System) received FDA 510(k) clearance on 2023-06-06, under approval number K220117.

What company makes ARC Intensive Care Information System (ARC System)?

ARC Intensive Care Information System (ARC System) is manufactured by Ordinatrum Solutions.

What is the FDA product code for ARC Intensive Care Information System (ARC System)?

The FDA product code for ARC Intensive Care Information System (ARC System) is MWI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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