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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 K182822
Device Name Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
Applicant
Taiwan Aulisa Medical Devices Technologies, Inc.
Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., Nangang Dist.
Taipei City,  TW 115
Applicant Contact Paul Liu
Correspondent
Don Mizota
725 Morninghome Road
Danville,  CA  94526
Correspondent Contact Don Mizota
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/04/2018
Decision Date 03/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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