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
Phone
651 4215870

Products

Device Name Product Code
Stimulator, Auditory, Evoked Response GWJ

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