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FDA 510(k)

MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS

K-Number: K012171 · 2001-07-24

ApplicantVisicu, Inc.
Decision Date2001-07-24
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS is the device name listed in this FDA 510(k) record. The listed applicant is Visicu, Inc.. It received FDA 510(k) clearance on 2001-07-24 under 510(k) number K012171. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS?

MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS is a medical device that received FDA 510(k) clearance on 2001-07-24. The listed applicant is Visicu, Inc.. The 510(k) number is K012171.

When did MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS receive FDA 510(k) clearance?

MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS received FDA 510(k) clearance on 2001-07-24, under 510(k) number K012171.

Who is the listed applicant for MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS?

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

What is the FDA product code for MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS?

The FDA product code for MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS is MSX.

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 Visicu, 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.

K211046eCareManager 4.5K171322eCareManager 4.1K171029eCareCoordinatorK153156eCareManager 4.0.1K001972ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK

Related Devices (Code: MSX)

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.

K261287Digistat CareAscom Ums Srl UnipersonaleK260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270TigerConnect Alarm ManagementTigerconnectK242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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