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FDA 510(k)

Aulisa Multiple Patient Digital Vital Sign Monitoring System

K-Number: K202497 · 2020-10-30

ApplicantTaiwan Aulisa Medical Devices Technologies, Inc.
Decision Date2020-10-30
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aulisa Multiple Patient Digital Vital Sign Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K202497. 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 Aulisa Multiple Patient Digital Vital Sign Monitoring System?

Aulisa Multiple Patient Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K202497.

When did Aulisa Multiple Patient Digital Vital Sign Monitoring System receive FDA 510(k) clearance?

Aulisa Multiple Patient Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2020-10-30, under 510(k) number K202497.

Who is the listed applicant for Aulisa Multiple Patient Digital Vital Sign Monitoring System?

The FDA 510(k) record lists Taiwan Aulisa Medical Devices Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aulisa Multiple Patient Digital Vital Sign Monitoring System?

The FDA product code for Aulisa Multiple Patient Digital Vital Sign Monitoring System 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.

NCT06415656VitalTraq for the Detection of CRSCOMPLETEDNCT07186738Study of a Patient Cohort Following Digestive Surgical Care After the Implementation of a Telemonitoring and Tele-coordination Platform for Medical, Paramedical, and Social ManagementRECRUITINGNCT07585019Ventilator Study in the NICUNOT_YET_RECRUITINGNCT07362641Clinical Validation of Non-Contact Vital SignsCOMPLETEDNCT07622485In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE)NOT_YET_RECRUITINGNCT02907255Vital Sign Monitoring With Continuous Pulse Oximetry and Wireless Clinician Notification After SurgeryCOMPLETED

Other records listing Taiwan Aulisa Medical Devices Technologies, 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.

K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)K240220Aulisa Temperature Module (TM0002)K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemK191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemK183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

View all 9 devices →

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.

K260211Dashboard (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.K242750Central StationNihon Kohden Digital Health Solutions, LLC

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.

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