Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System

System, Network And Communication, Physiological Monitors

Taiwan Aulisa Medical Devices Technologies, Inc.

The following data is part of a premarket notification filed by Taiwan Aulisa Medical Devices Technologies, Inc. with the FDA for Guardian Angel Rx Ga2000 Series Digital Vital Sign Monitoring System.

Pre-market Notification Details

Device IDK203208
510k NumberK203208
Device Name:Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant Taiwan Aulisa Medical Devices Technologies, Inc. Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., Nangang Dist. Taipei,  TW 115
ContactPaul Liu
CorrespondentDon Mizota
Don Mizota 725 Morninghome Road Danville,  CA  94526
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-30
Decision Date2022-06-12

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