Aulisa Multiple Patient 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 Aulisa Multiple Patient Digital Vital Sign Monitoring System.

Pre-market Notification Details

Device IDK202497
510k NumberK202497
Device Name:Aulisa Multiple Patient Digital Vital Sign Monitoring System
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant Taiwan Aulisa Medical Devices Technologies, Inc. Rm. 1052, Bldg. H, 10F., No.3­2, YuanQu St., Nangang Dist. Taipei City,  TW
ContactPaul Liu
CorrespondentDon Mizota
Taiwan Aulisa Medical Devices Technologies, Inc. 725 Morninghome Road Danville,  CA  94526
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2020-10-30

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.