FDA Registration
Active
🇮🇱 Israel
REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
Reg #: 3008881835
·
FEI: 3008881835
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COMMWELL RESEARCH AND DEVELOPMENT LTD
- Registration Number
- 3008881835
- FEI Number
- 3008881835
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- yad haruzim 4
- City
- kfar saba Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K010791
Owner / Operator
- Firm Name
- Commwell Research and Development Ltd
- Operator Number
- 10035078
- Address
- yad haruzim 4
- City
- kfar saba
- State
- IL-NOTA
- Postal Code
- 4464102
- Country
- IL
- Correspondent
- Doron David
US Agent
- Business Name
- Advanced Data Systems Corporation
- Contact Name
- David Barzillai
- Address
- 15 Prospect St
- City
- Paramus
- State
- NJ
- ZIP
- 07652
- Country
- US
- [email protected]
- Phone
- 201 2891449 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2011-02-01 |
Proprietary Names
REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
Establishment Types
Manufacture Medical Device