Natus Neurology Inc
⚠️ Moderate Risk
FEI: 3010611950 • Middleton, WI • UNITED STATES
FEI Number
3010611950
Location
Middleton, WI
Country
UNITED STATESAddress
3150 Pleasant View Rd, , Middleton, WI, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/6/2020 | 84GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 4/6/2020 | 84GWQELECTROENCEPHALOGRAPH | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 1/3/2014 | 84GXYELECTRODE, CUTANEOUS | New Orleans District Office (NOL-DO) | |
| 1/3/2014 | 84GYBMEDIA, ELECTROCONDUCTIVE | New Orleans District Office (NOL-DO) | |
| 1/3/2014 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | New Orleans District Office (NOL-DO) | |
| 10/25/2013 | 74DPSELECTROCARDIOGRAPH | New Orleans District Office (NOL-DO) | |
| 4/11/2002 | 77EWOAUDIOMETER | 118NOT LISTED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Natus Neurology Inc's FDA import refusal history?
Natus Neurology Inc (FEI: 3010611950) has 7 FDA import refusal record(s) in our database, spanning from 4/11/2002 to 4/6/2020.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Natus Neurology Inc's FEI number is 3010611950.
What types of violations has Natus Neurology Inc received?
Natus Neurology Inc has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Natus Neurology Inc come from?
All FDA import refusal data for Natus Neurology Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.