The following data is part of a premarket notification filed by American Thermal Instruments, Inc. with the FDA for Ati Forehead Thermometer.
Device ID | K832651 |
510k Number | K832651 |
Device Name: | ATI FOREHEAD THERMOMETER |
Classification | Strip, Temperature, Forehead, Liquid Crystal |
Applicant | AMERICAN THERMAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPD |
CFR Regulation Number | 880.2200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-08 |
Decision Date | 1983-10-04 |