Natus 515-013900
by Natus Neurology Incorporated
Natus 515-013900 is a Class II device made by Natus Neurology Incorporated, cleared under FDA 510(k) K890495 on 16 Mar 1989 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00382830037532), 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 | Number00382830037532 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK890495 | Date16 Mar 1989 | StatusActive |
Official records
- AccessGUDID record 00382830037532
- FDA 510(k) database K890495
Across registries
- FDA 510(k) K890495 decided 16 Mar 1989 Active
- FDA GUDID UDI-DI 00382830037532 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K890495
- Listed FDA GUDID 00382830037532
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Natus
- Generic name
- Electromyograph
- Model / reference
- 515-013900
- Primary DI / UDI-DI
- 00382830037532
- 510(k) Number
- FDA product code
- IKN
- GMDN term
- Electromyograph
- Device class
- Class II
- Regulation number
- 890.1375
- GUDID distribution status
- In Commercial Distribution
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