The following data is part of a premarket notification filed by Kaz, Inc. with the FDA for Behind Ear Gentle Touch Thermometer.
| Device ID | K103839 |
| 510k Number | K103839 |
| Device Name: | BEHIND EAR GENTLE TOUCH THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | KAZ, INC. 250 TURNPIKE ROD Southborough, MA 01772 |
| Contact | Raj S Kasbekar |
| Correspondent | Raj S Kasbekar KAZ, INC. 250 TURNPIKE ROD Southborough, MA 01772 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-30 |
| Decision Date | 2011-06-06 |