FDA Registration
Active
🇮🇱 Israel
Oxitone 1000M
Reg #: 3015143060
·
FEI: 3015143060
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OXITONE MEDICAL LTD.
- Registration Number
- 3015143060
- FEI Number
- 3015143060
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17 Atir Yeda Street
- City
- Kfar Saba Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K163382
Owner / Operator
- Firm Name
- Oxitone Medical Ltd.
- Operator Number
- 10059600
- Address
- 17 Atir Yeda Street
- City
- Kfar Saba
- State
- IL-NOTA
- Postal Code
- 4464312
- Country
- IL
- Correspondent
- Leon Eisen
US Agent
- Business Name
- ProMedic Consulting LLC
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr NE
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076060
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-02-02 |
Proprietary Names
Oxitone 1000M
Oxitone 1000
Establishment Types
Manufacture Medical Device