The following data is part of a premarket notification filed by Kaz Usa, Inc., A Helen Of Troy Company with the FDA for Vdt985us Vicks Smarttemp Thermometer.
| Device ID | K152975 |
| 510k Number | K152975 |
| Device Name: | VDT985US Vicks SmartTemp Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Kaz USA, Inc., A Helen Of Troy Company 250 Turnpike Road Southborough, MA 01772 |
| Contact | Raj Kasbekar |
| Correspondent | Raj Kasbekar Kaz USA, Inc., A Helen Of Troy Company 250 Turnpike Road Southborough, MA 01772 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-08 |
| Decision Date | 2016-03-23 |
| Summary: | summary |