The following data is part of a premarket notification filed by Hangzhou Universal Electronic Co., Ltd. with the FDA for Infrared Forehead Thermometer, Ft-100a.
| Device ID | K160802 |
| 510k Number | K160802 |
| Device Name: | Infrared Forehead Thermometer, FT-100A |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HANGZHOU UNIVERSAL ELECTRONIC CO., LTD. 38 YANGJIATANG, SANDUN, WESTLAKE DISTRICT Hangzhou City, CN 310030 |
| Contact | Jiaqiang Wan |
| Correspondent | Charlie Mack IRC 7808 RUSH CREEK DRIVE Pasco, WA 99301 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-23 |
| Decision Date | 2016-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001625813 | K160802 | 000 |
| 00049696731621 | K160802 | 000 |