Natus 010382
by Xltek
Natus 010382 is a Class II device made by Xltek, cleared under FDA 510(k) K991903 on 4 Aug 1999 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00382830015950), 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 | Number00382830015950 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK991903 | Date4 Aug 1999 | StatusActive |
Official records
- AccessGUDID record 00382830015950
- FDA 510(k) database K991903
Across registries
- FDA 510(k) K991903 decided 4 Aug 1999 Active
- FDA GUDID UDI-DI 00382830015950 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K991903
- Listed FDA GUDID 00382830015950
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Natus
- Generic name
- Electromyograph
- Model / reference
- 010382
- Primary DI / UDI-DI
- 00382830015950
- 510(k) Number
- FDA product code
- GWE
- GMDN term
- Electromyograph
- Device class
- Class II
- Regulation number
- 882.1890
- GUDID distribution status
- In Commercial Distribution
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