FDA Registration
Active
🇮🇱 Israel
RESPeRATE
Reg #: 3013263129
·
FEI: 3013263129
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- 2BREATHE TECHNOLOGIES LTD
- Registration Number
- 3013263129
- FEI Number
- 3013263129
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 16 Hatidhar St.
- City
- Raanana Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K020399
Owner / Operator
- Firm Name
- 2breathe technologies LTD
- Operator Number
- 10052413
- Address
- 16 Hatidhar St.
- City
- Raanana
- State
- IL-NOTA
- Postal Code
- 43652
- Country
- IL
- Correspondent
- George Hattub
US Agent
- Business Name
- Medicsense USA
- Contact Name
- George Hattub
- Address
- 291 Hillside Ave
- City
- Somerset
- State
- MA
- ZIP
- 02726
- Country
- US
- [email protected]
- Phone
- 508 4796116
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2016-07-25 |
Proprietary Names
RESPeRATE
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility