The following data is part of a premarket notification filed by Kaz Usa, Inc., A Helen Of Troy Company with the FDA for Braun No Touch + Forehead Ntf3000 Thermometer.
Device ID | K163516 |
510k Number | K163516 |
Device Name: | Braun No Touch + Forehead NTF3000 Thermometer |
Classification | Thermometer, Electronic, Clinical |
Applicant | Kaz USA, Inc., A Helen Of Troy Company 400 Donald Lynch Boulevard Suite 300 Marlborough, MA 01752 |
Contact | Rajesh Kasbekar |
Correspondent | Rajesh Kasbekar 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 | 2016-12-15 |
Decision Date | 2017-04-21 |
Summary: | summary |