Natus 040C001
by Natus Neurology Incorporated
Natus 040C001 is a Class II device made by Natus Neurology Incorporated, cleared under FDA 510(k) K965065 on 20 Jun 1997 and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 00382830043519), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00382830043519 | Date14 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK965065 | Date20 Jun 1997 | StatusActive |
Official records
- AccessGUDID record 00382830043519
- FDA 510(k) database K965065
Across registries
- FDA 510(k) K965065 decided 20 Jun 1997 Active
- FDA GUDID UDI-DI 00382830043519 listed 14 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K965065
- Listed FDA GUDID 00382830043519
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Natus
- Generic name
- Electromyograph
- Model / reference
- 040C001
- Primary DI / UDI-DI
- 00382830043519
- 510(k) Number
- FDA product code
- GWF
- GMDN term
- Electromyograph
- Device class
- Class II
- Regulation number
- 882.1870
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GWF (Stimulator, Electrical, Evoked Response).
- 533626 by inomed Medizintechnik GmbH
- 534672 by inomed Medizintechnik GmbH
- Nomad TM-3400 by Tracor Northern, Inc.
- PROTEKTOR 32 by Natus Medical, Inc.
- BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM by Bio-Logic Systems Corp.
- Xltek Evoked Potential Headbox, Model EP-4-RP by Excel Tech., Ltd.
- MagPro Cool-B70 9016E0521 by Tonica Elektronik A/S
- MagPro Accessories Flow Arm 9016B0801 by Tonica Elektronik A/S
- TN-3000 EVOKED RESPONSE SYSTEM by Tracor Northern, Inc.
- MEGA-TMS by SOTERIX MEDICAL,INC.