Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System

Oximeter

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 Ga2001 Digital Vital Sign Monitoring System.

Pre-market Notification Details

Device IDK191207
510k NumberK191207
Device Name:Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
ClassificationOximeter
Applicant Taiwan Aulisa Medical Devices Technologies, Inc. Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., Nangang Dist. Taipei City,  TW 115
ContactPaul Liu
CorrespondentDon Mizota
Don Mizota 725 Morninghome Road Danville,  CA  94526
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-06
Decision Date2019-06-25

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