The following data is part of a premarket notification filed by Radiant Innovation, Inc. with the FDA for Rii Infrared Ear Thermometer, Models Th5xy Series.
Device ID | K063185 |
510k Number | K063185 |
Device Name: | RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES |
Classification | Thermometer, Electronic, Clinical |
Applicant | RADIANT INNOVATION, INC. 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 300 |
Contact | Frank Lin |
Correspondent | Frank Lin RADIANT INNOVATION, INC. 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 300 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-20 |
Decision Date | 2006-11-17 |
Summary: | summary |