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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K162580
Device Name Guardian Angel GA1000 Digital Vital Sign Monitoring System
Applicant
Taiwan Aulisa Medical Devices Technologies, Inc.
Rm. 1052, Bldg. H, 10f., # 3-2, Yuanqu St.,
Nangang Dist.
Taipei,  TW 115
Applicant Contact ALAN TANG
Correspondent
Taiwan Aulisa Medical Devices Technologies, Inc.
725 Morninghome Rd.
Danville,  CA  94526
Correspondent Contact DON MIZOTA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/15/2016
Decision Date 03/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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