The following data is part of a premarket notification filed by Radiant Innovation Inc. with the FDA for Rii Multi-function Infrared Thermometer, Model Th52z.
Device ID | K162083 |
510k Number | K162083 |
Device Name: | RII Multi-function Infrared Thermometer, Model TH52Z |
Classification | Thermometer, Electronic, Clinical |
Applicant | Radiant Innovation Inc. 1F, No.3 Industrial E. 9th Rd. Science-Based, Industrial Park Hsinchu, TW 30075 |
Contact | Monica Chung |
Correspondent | Monica Chung Radiant Innovation Inc. 1F, No.3 Industrial E. 9th Rd. Science-Based, Industrial Park Hsinchu, TW 30075 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-27 |
Decision Date | 2017-01-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810025921088 | K162083 | 000 |