FDA 510(k)

Aulisa Multiple Patient Digital Vital Sign Monitoring System

Numéro K : K202497 · 2020-10-30

DemandeurTaiwan Aulisa Medical Devices Technologies, Inc.

Date de décision2020-10-30

Code produitMSX

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Taiwan Aulisa Medical Devices Technologies, Inc. en tant que demandeur

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 System K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

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Dispositifs connexes (Code : MSX)

K261287Digistat CareAscom Ums Srl Unipersonale K260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH K243270TigerConnect Alarm ManagementTigerconnect K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Source officielle

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