The following data is part of a premarket notification filed by Radiant Innovation Inc. with the FDA for Rii Infrared Ear Thermometer, Model: Th60n.
Device ID | K101253 |
510k Number | K101253 |
Device Name: | RII INFRARED EAR THERMOMETER, MODEL: TH60N |
Classification | Thermometer, Electronic, Clinical |
Applicant | RADIANT INNOVATION INC. 1F, NO. 3 INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK, Hsin Chu, TW |
Contact | James Huang |
Correspondent | James Huang RADIANT INNOVATION INC. 1F, NO. 3 INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK, Hsin Chu, TW |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-05-04 |
Decision Date | 2010-06-29 |
Summary: | summary |