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 |