FDA Registration
Active
🇮🇱 Israel
NICOM sensor
Reg #: 3005004021
·
FEI: 3005004021
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Baxter Healthcare - Tel Aviv
- Registration Number
- 3005004021
- FEI Number
- 3005004021
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2A Hashlosha St. F-32
- City
- Tel Aviv
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K101487
Owner / Operator
- Firm Name
- BAXTER HEALTHCARE CORPORATION
- Operator Number
- 1417572
- Address
- One Baxter Parkway
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Maha Nolasco
US Agent
- Business Name
- BAXTER HEALTHCARE CORPORATION
- Contact Name
- Maha Nolasco
- Address
- 25212 W. IL Route 120, RLT-04
- City
- Round Lake
- State
- IL
- ZIP
- 60073
- Country
- US
- [email protected]
- Phone
- 224 2706181
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2022-11-16 |
Proprietary Names
NICOM sensor
Baxter Starling Sensor
Pre-wired NICOM Sensor
Cheetah Sensors
Prewired Electrode of Cheetah Medical
NICOM Electrodes
Electrode
Starling Sensors
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device