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)

ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION

K-Number: K110535 · 2012-03-26

ApplicantCarefusion 303, Inc.
Decision Date2012-03-26
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 303, Inc.. It received FDA 510(k) clearance on 2012-03-26 under 510(k) number K110535. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION?

ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION is a medical device that received FDA 510(k) clearance on 2012-03-26. The listed applicant is Carefusion 303, Inc.. The 510(k) number is K110535.

When did ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION receive FDA 510(k) clearance?

ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION received FDA 510(k) clearance on 2012-03-26, under 510(k) number K110535.

Who is the listed applicant for ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION?

The FDA 510(k) record lists Carefusion 303, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION?

The FDA product code for ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION is FRN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Carefusion 303, Inc. as applicant

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.

K243855BD Alaris Infusion System with Guardrails Suite MXK211218BD Alaris System with Guardrails Suite MX v12.1.2K171957MaxZero Extension Sets with Needless ConnectorK163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemK110809WIRELESS MONITORING SYSTEM

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.

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.

↑