The following data is part of a premarket notification filed by Radiant Innovation, Inc. with the FDA for Infrared Ear Thermometer.
Device ID | K103097 |
510k Number | K103097 |
Device Name: | INFRARED EAR THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | RADIANT INNOVATION, INC. 1F,NO. 3,INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 300 |
Contact | James Huang |
Correspondent | James Huang 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 | 2010-10-20 |
Decision Date | 2010-12-29 |
Summary: | summary |