The following data is part of a premarket notification filed by Tyto Care Ltd. with the FDA for Tyto Stethoscope (otc).
| Device ID | K181612 |
| 510k Number | K181612 |
| Device Name: | Tyto Stethoscope (OTC) |
| Classification | Stethoscope, Electronic |
| 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 | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-06-19 |
| Decision Date | 2018-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016672190 | K181612 | 000 |