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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K202497
Device Name Aulisa Multiple Patient Digital Vital Sign Monitoring System
Applicant
Taiwan Aulisa Medical Devices Technologies, Inc.
Rm. 1052, Bldg. H, 10f., #3­2, Yuanqu St., Nangang Dist.
Taipei,  TW 115
Applicant Contact Paul Liu
Correspondent
Taiwan Aulisa Medical Devices Technologies, Inc.
725 Morninghome Rd.
Danville,  CA  94526
Correspondent Contact Don Mizota
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Code
MWI  
Date Received08/31/2020
Decision Date 10/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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