The following data is part of a premarket notification filed by Tyto Care Ltd. with the FDA for Tyto Stethoscope.
| Device ID | K160401 |
| 510k Number | K160401 |
| Device Name: | Tyto Stethoscope |
| Classification | Stethoscope, Electronic |
| Applicant | Tyto Care Ltd. Haomanut 12 Netanya, IL 4205445 |
| Contact | Yoni Iger |
| Correspondent | Orna Oz BioMedical Strategy 155 Bialik St. Ramat Gan, IL 5252346 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-12 |
| Decision Date | 2016-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016672046 | K160401 | 000 |
| 07290016672015 | K160401 | 000 |