Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Ordinatrum Solutions. It received FDA 510(k) clearance on 2023-06-06 under 510(k) 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. The listed applicant is Ordinatrum Solutions. The 510(k) number is K220117.

When did ARC Intensive Care Information System (ARC System) receive FDA 510(k) clearance?

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

Who is the listed applicant for ARC Intensive Care Information System (ARC System)?

The FDA 510(k) record lists Ordinatrum Solutions as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

Official Source

View on FDA Database →

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

↑