The following data is part of a premarket notification filed by Tyto Care Ltd. with the FDA for Tyto Thermometer.
| Device ID | K190242 |
| 510k Number | K190242 |
| Device Name: | Tyto Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Tyto Care Ltd. 12 Haomanut Street Netanya, IL 4250445 |
| Contact | Stella Raizelman Perry |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-02-06 |
| Decision Date | 2019-03-27 |