FDA Registration
Active
🇮🇱 Israel
Tyto Insights for Wheeze Detection
Reg #: 3012678246
·
FEI: 3012678246
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TYTOCARE LTD.
- Registration Number
- 3012678246
- FEI Number
- 3012678246
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14 Beni Gaon St.
- City
- Netanya Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K232237
Owner / Operator
- Firm Name
- Tytocare Ltd.
- Operator Number
- 10052860
- Address
- 14 Beni Gaon St.
- City
- Netanya
- State
- IL-NOTA
- Postal Code
- 4250803
- Country
- IL
- Correspondent
- Stella Raizelman Perry
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abnormal Breath Sound Device | PHZ | Class 2 | Anesthesiology | No | 2023-12-19 |
Proprietary Names
Tyto Insights for Wheeze Detection
Establishment Types
Manufacture Medical Device