The following data is part of a premarket notification filed by Radiant Innovation Inc. with the FDA for Non-contact Clinical Thermometer.
Device ID | K121428 |
510k Number | K121428 |
Device Name: | NON-CONTACT CLINICAL THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | RADIANT INNOVATION INC. 1F, NO.3, INDUSTRIAL E. 9TH RD SCIENCE-BASED INDUSTRIAL PARK Hsinchu, TW 30075 |
Contact | James Huang |
Correspondent | James Huang 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 | 2012-05-14 |
Decision Date | 2012-07-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884392626024 | K121428 | 000 |
50666519700036 | K121428 | 000 |
10860003705305 | K121428 | 000 |
00194484319427 | K121428 | 000 |
00860003705315 | K121428 | 000 |
00840177900006 | K121428 | 000 |
00073796507206 | K121428 | 000 |