The following data is part of a premarket notification filed by Kaz Usa, Inc., A Helen Of Troy Company with the FDA for Braun Bfh175 Infrared Forehead Thermometer.
| Device ID | K181015 |
| 510k Number | K181015 |
| Device Name: | Braun BFH175 Infrared Forehead Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Kaz USA, Inc., A Helen Of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough, MA 01752 |
| Contact | Matt J. Baun |
| Correspondent | Matt J. Baun Kaz USA, Inc., A Helen Of Troy Company 400 Donald Lynch Boulevard, 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 | 2018-04-17 |
| Decision Date | 2018-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10328785001676 | K181015 | 000 |