The following data is part of a premarket notification filed by Conmo Electronic Company Limited with the FDA for Infrared Forehead Thermometer.
Device ID | K202420 |
510k Number | K202420 |
Device Name: | Infrared Forehead Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Conmo Electronic Company Limited Suiyi Town, Xincheng County Laibin City, CN |
Contact | Ying Qi |
Correspondent | Charles Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-24 |
Decision Date | 2021-02-25 |