Natus 014161
by Xltek
Natus 014161 is a Class II device made by Xltek, cleared under FDA 510(k) K143440 on 20 Apr 2015 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00382830016339), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00382830016339 | Date13 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK143440 | Date20 Apr 2015 | StatusActive |
Official records
- AccessGUDID record 00382830016339
- FDA 510(k) database K143440
Across registries
- FDA 510(k) K143440 decided 20 Apr 2015 Active
- FDA GUDID UDI-DI 00382830016339 listed 13 Sep 2016 Listed
Recalls
-
- Terminated Z-0581-2016
During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity.
Timeline
- Cleared FDA 510(k) K143440
- Recall initiated FDA recalls Z-0581-2016
- Listed FDA GUDID 00382830016339
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Natus
- Generic name
- Electroencephalograph
- Model / reference
- 014161
- Primary DI / UDI-DI
- 00382830016339
- 510(k) Number
- FDA product code
- GWQ
- GMDN term
- Electroencephalograph
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- In Commercial Distribution
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