Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name oximeter
510(k) Number K191207
Device Name Guardian Angel Rx GA2001 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  
Subsequent Product Code
DRG  
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
-
-