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 Continuous Measurement Thermometer
510(k) Number K160999
Device Name Infra-red forehead thermometer
Applicant
Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
Bldg. 2, 1# Fuzhu Nan Rd., Wuchang Town, Yuhang District
Hangzhou,  CN 310023
Applicant Contact AHNEO YANG
Correspondent
Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
Bldg. 2, 1# Fuzhu Nan Rd., Wuchang Town, Yuhang District
Hangzhou,  CN 310023
Correspondent Contact AHNEO YANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/11/2016
Decision Date 08/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-