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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 K191207
Device Name Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
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
Don Mizota
725 Morninghome Road
Danville,  CA  94526
Correspondent Contact Don Mizota
Regulation Number870.2700
Classification Product Code
Subsequent Product Code
Date Received05/06/2019
Decision Date 06/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No