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 |