The following data is part of a premarket notification filed by Radiant Innovation, Inc. with the FDA for Infrared Ear Thermometer, Models Th88 Series.
| Device ID | K020504 |
| 510k Number | K020504 |
| Device Name: | INFRARED EAR THERMOMETER, MODELS TH88 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-15 |
| Decision Date | 2002-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50666519700012 | K020504 | 000 |