• 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 thermometer, electronic, clinical
510(k) Number K200531
Device Name iHealth Infrared No-Touch Forehead Thermometer
Applicant
Andon Health Co., Ltd.
No. 3 Jin Ping Street,Ya An Road, Nankai District
tianjin,  CN 300190
Applicant Contact liu yi
Correspondent
Andon Health Co., Ltd.
No. 3 Jin Ping Street,Ya An Road, Nankai District
tianjin,  CN 300190
Correspondent Contact liu yi
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/02/2020
Decision Date 07/15/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-