The following data is part of a premarket notification filed by Radiant Innovation, Inc. with the FDA for Infared Ear Thermometer, Model Th8 Series.
| Device ID | K011059 |
| 510k Number | K011059 |
| Device Name: | INFARED EAR THERMOMETER, MODEL TH8 SERIES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RADIANT INNOVATION, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk RADIANT INNOVATION, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-06 |
| Decision Date | 2001-09-17 |