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
Phone
224 2706181

Products

Device Name Product Code
Computer, Diagnostic, Pre-Programmed, Single-Function DXG

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