FDA Registration
Active
🇨🇦 Canada
036234ALGO Pro ATA Cables, 36 inch
Reg #: 9612330
·
FEI: 3002809369
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
- Registration Number
- 9612330
- FEI Number
- 3002809369
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2568 BRISTOL CIR.
- City
- OAKVILLE Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K233649
Owner / Operator
- Firm Name
- Natus Medical Incorporated
- Operator Number
- 9004873
- Address
- 3150 Pleasant View Road
- City
- Middleton
- State
- WI
- Postal Code
- 53562
- Country
- US
US Agent
- Business Name
- Natus
- Contact Name
- Courtney Walton
- Address
- 3610 County Road 101 S
- City
- Wayzata
- State
- MN
- ZIP
- 55391
- Country
- US
- [email protected]
- Phone
- 651 4215870
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2024-03-21 |
Proprietary Names
036234ALGO Pro ATA Cables, 36 inch
036235ALGO Pro ATA Cables, 72 inch
040546ALGO-Pack
041554ALGO Pro Bassinet Hook
040670Valu-Pack
036244ALGO Pro Docking Station
036243ALGO Pro Mobile Cart
040587Jelly Tab Electrodes
036236ALGO Pro PCA Cables, 36 inch
042055ALGO Pro DC-DC converter module
036237ALGO Pro PCA Cables, 72 inch
036177ALGO Pro Newborn Hearing Screening Device
011445Flexicoupler and Jellytab Combo Pack
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility