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 Thermometer, Electronic, Clinical
510(k) Number K101253
Device Name RII INFRARED EAR THERMOMETER, MODEL: TH60N
Applicant
RADIANT INNOVATION INC.
1F, NO. 3 INDUSTRIAL E. 9TH RD
SCIENCE-BASED INDUSTRIAL PARK,
HSIN CHU,  TW
Applicant Contact JAMES HUANG
Correspondent
RADIANT INNOVATION INC.
1F, NO. 3 INDUSTRIAL E. 9TH RD
SCIENCE-BASED INDUSTRIAL PARK,
HSIN CHU,  TW
Correspondent Contact JAMES HUANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/04/2010
Decision Date 06/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-