The following data is part of a premarket notification filed by Kaz Usa, Inc., A Helen Of Troy Company with the FDA for The Braun Thermoscan® 3 High Speed Compact Ear Thermometer.
| Device ID | K161933 |
| 510k Number | K161933 |
| Device Name: | The Braun ThermoScan® 3 High Speed Compact Ear Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Kaz USA, Inc., A Helen Of Troy Company 400 DONALD LYNCH BLVD., SUITE 300 Marlborough, MA 01752 |
| Contact | Amy Liu |
| Correspondent | Amy Liu Kaz USA, Inc., A Helen Of Troy Company 400 DONALD LYNCH BLVD., SUITE 300 Marlborough, MA 01752 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-14 |
| Decision Date | 2016-08-16 |
| Summary: | summary |