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 |